|
|
Recent news from the US Food and Drug Administration.
Click title to see the full article at the FDA
website. For the most up-to-date headlines, check out the FDA
Newsroom. Press announcements from 2004 to 2009 are available through
the FDA
Archive.
FDA
Recalls: FDA posts press releases and other notices of recalls and
market withdrawals from the firms involved as a service to consumers,
the media, and other interested parties. FDA does not endorse either the
product or the company. This site does not contain a complete list of
recalls -
search for recalls at the official FDA site.
| December 21, 2018 - FDA
permits marketing of a diagnostic test to aid in measuring nutrients
in breast milk |
| December 21, 2018 - FDA
approves new treatment for adult patients with rare, life-threatening
blood disease |
| December 21, 2018 - FDA
approves first treatment for rare blood disease |
| December 20, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture
Improvement Act and the agency’s regulation of products containing
cannabis and cannabis-derived compounds |
| December 20, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen
the long-term safety oversight of the Essure device following discontinuation
of its U.S. sales |
| December 20, 2018 - FDA
warns about safety risks of teething necklaces, bracelets to relieve
teething pain or to provide sensory stimulation |
| December 20, 2018 -
FDA sends warning to company for marketing dangerous unapproved stem
cell products that put patients at risk and puts other stem cell firms,
providers on notice |
| December 18, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D.,
Director of the Center for Devices and Radiological Health, on new
steps to promote innovations in medical devices that help advance
patient safety |
| December 18, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s 2017
report on declining sales/distribution of antimicrobial drugs for
food animals, a reflection of improved antimicrobial stewardship |
| December 17, 2018 - Michigan-based
food manufacturer agrees to stop operations after repeated food safety
violations |
| December 13, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner
Frank Yiannas on new findings and updated consumer recommendations
related to the romaine lettuce E. coli O157:H7 outbreak investigation |
| December 13, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D. and Director of FDA’s
Center for Drug Evaluation and Research Janet Woodcock, M.D., on efforts
to modernize generic drug labels while maintaining the efficiency
of generic development |
| December 12, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts
to improve drug quality through vigilant oversight of data integrity
and good manufacturing practice |
| December 11, 2018 - FDA
warns API manufacturer involved in valsartan recall, provides information
for patients taking these medications |
| December 11, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing
the agency’s biosimilars policy framework |
| December 10, 2018 - Statement
from Jeff Shuren, M.D., J.D., Director of the Center for Devices and
Radiological Health, on updated safety communication about rates of
duodenoscope contamination from preliminary postmarket data |
| December 10, 2018 - FDA
clears mobile medical app to help those with opioid use disorder stay
in recovery programs |
| December 10, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner
Anna Abram on new efforts to assure the quality of compounded drugs |
|
December 06, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic
framework to advance use of real-world evidence to support development
of drugs and biologics
|
| December 06, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new
effort for developing and class labeling of in vitro companion diagnostics
for classes of oncology therapeutic products |
|
December 04, 2018 - FDA
takes new action to advance the development of reliable and beneficial
genetic tests that can improve patient care
|
| November 30, 2018 - FDA
authorizes first test to aid in detecting a type of herpes virus in
newborns called cytomegalovirus |
| November 29, 2018 - FDA
warns company for selling e-liquids that resemble kid-friendly foods
as part of the agency’s ongoing Youth Tobacco Prevention Plan |
| November 28, 2018 - FDA
approves first treatment for Lambert-Eaton myasthenic syndrome, a
rare autoimmune disorder |
| November 28, 2018 - FDA
approves treatment for adult patients who have relapsed or refractory
acute myeloid leukemia (AML) with a certain genetic mutation |
| November 28, 2018 - FDA
approves first biosimilar for treatment of adult patients with non-Hodgkin’s
lymphoma |
| November 27, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates
can promote innovation and advance safety and effectiveness of medical
devices that use 510(k) pathway |
| November 27, 2018 - Statement
by FDA Commissioner Scott Gottlieb, M.D., on risk of heavy metals,
including nickel and lead, found in some kratom products |
| November 27, 2018 - FDA
warns consumers to avoid Rhino male enhancement products found at
retailers because of undeclared and potentially dangerous drug ingredients |
| November 26, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the current romaine
lettuce E. coli O157:H7 outbreak investigation |
| November 26, 2018 - FDA
approves an oncology drug that targets a key genetic driver of cancer,
rather than a specific type of tumor |
| November 26, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D.,
Director of the Center for Devices and Radiological Health, on transformative
new steps to modernize FDA’s 510(k) program to advance the review
of the safety and effectiveness of medical devices |
| November 21, 2018 - FDA
approves new treatment for patients with acute myeloid leukemia |
| November 20, 2018 - FDA
warns marketers of products labeled as dietary supplements that contain
tianeptine for making unproven claims to treat serious conditions,
including opioid use disorder |
| November 20, 2018 -
Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren,
M.D., Director of the Center for Devices and Radiological Health,
on FDA’s updates to Medical Device Safety Action Plan to enhance
post-market safety |
| November 20, 2018 - FDA
approves first treatment specifically for patients with rare and life-threatening
type of immune disease |
| November 19, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health
claim for consuming oils with high levels of oleic acid to reduce
coronary heart disease risk |
| November 16, 2018 - FDA
approves new drug to treat travelers’ diarrhea |
| November 16, 2018 - Statement
from USDA Secretary Perdue and FDA Commissioner Gottlieb on the regulation
of cell-cultured food products from cell lines of livestock and poultry |
| November 16, 2018 - Statement
by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s efforts
to hold industry accountable for fulfilling critical post-marketing
studies of the benefits, safety of new drugs |
| November 16, 2018 - FDA
approves first-line treatment for peripheral T-cell lymphoma under
new review pilot |
| November 16, 2018 - Statement
by FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce animal
testing through a study aimed at eliminating the use of dogs in certain
trials |
| November 15, 2018 - Results
from 2018 National Youth Tobacco Survey show dramatic increase in
e-cigarette use among youth over past year |
| November 15, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps
to protect youth by preventing access to flavored tobacco products
and banning menthol in cigarettes |
| November 14, 2018 - FDA
alerts doctors, patients about risk of complications when certain
implanted pumps are used to deliver pain medications not approved
for use with the devices |
| November 13, 2018 - FDA
warns StemGenex Biologic Laboratories LLC of illegally marketing an
unapproved cellular product manufactured in a facility with significant
manufacturing violations, putting patients at risk |
| November 09, 2018 - FDA
seizes food and medical products held under insanitary conditions
at an Arkansas grocery warehouse |
| November 09, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen
and modernize agency’s oversight and reporting of inspections
for sterile injectable drugs |
| November 09, 2018 - FDA
authorizes emergency use of first Ebola fingerstick test with portable
reader |
| November 08, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen
FDA’s expanded access program |
| November 08, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D.,
director of the Center for Drug Evaluation and Research, on approval
of OTC Primatene Mist to treat mild asthma |
| November 05, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to
make more robust use of mandatory recall authority to quickly remove
unsafe foods from the market |
|
November 02, 2018 - FDA
permits marketing of two devices that detect parathyroid tissue
in real-time during surgery
|
| November 02, 2018 - FDA
and DoD formalize collaboration to advance medical products in support
of American military personnel |
| November 02, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on agency’s approval
of Dsuvia and the FDA’s future consideration of new opioids |
| November 02, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued
efforts to address growing epidemic of youth e-cigarette use, including
potential new therapies to support cessation |
| November 01, 2018 - FDA
warns patients and doctors about risk of inaccurate results from home-use
device to monitor blood thinner warfarin |
| November 01, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on findings from the romaine
lettuce E. coli O157:H7 outbreak investigation and FDA’s efforts
to prevent future outbreaks |
| November 01, 2018 - Statement
from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center
for Devices and Radiological Health on the National Toxicology Program’s
report on radiofrequency energy exposure |
| November 01, 2018 - Jeffrey
Shuren, M.D., J.D., director of the FDA’s Center for Devices
and Radiological Health and Janet Woodcock, M.D., director of the
FDA’s Center for Drug Evaluation and Research on agency’s
warning to consumers about genetic tests that claim to predict patients’
responses to specific medications |
| October 31, 2018 - FDA
authorizes first direct-to-consumer test for detecting genetic variants
that may be associated with medication metabolism |
| October 31, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry
related to the agency’s ongoing policy commitment to firmly address
rising epidemic rates in youth e-cigarette use |
| October 30, 2018 - FDA
takes action to stop the use of lead acetate in hair dyes |
| October 30, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner
Anna Abram on the FDA’s new plan to advance plant, animal biotechnology
innovation |
| October 29, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new
consideration of labeling for sesame allergies |
| October 24, 2018 - FDA
permits marketing of a diagnostic test to aid in the determination
of menopausal status |
| October 24, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on how new regulatory
authorities will assist the agency in more forcefully addressing opioid
crisis; included as part of the newly enacted Substance Use-Disorder
Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for
Patients and Communities Act |
| October 24, 2018 - FDA
approves new drug to treat influenza |
| October 23, 2018 - Federal
judge enters consent decree against Tennessee over-the-counter drug
manufacturer |
| October 23, 2018 - FDA
launches global operation to crack down on websites selling illegal,
potentially dangerous drugs; including opioids |
| October 23, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts
to advance new ways to increase the availability of naloxone as one
means for reducing opioid overdose deaths |
| October 22, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing
commitment to improving efficiency, transparency of tobacco product
application review process as part of FDA’s comprehensive framework
to reduce tobacco-related disease and death |
| October 19, 2018 - Statement
by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps
to help produce farmers, processors more effectively comply with food
safety requirements |
| October 18, 2018 - Trump
Administration Launches “Winning on Reducing Food Waste”
Initiative |
| October 16, 2018 - FDA
and DHS increase coordination of responses to medical device cybersecurity
threats under new partnership; a part of the two agencies’ broader
effort to protect patient safety |
| October 15, 2018 - Statement
by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps
to modernize drug development, improve efficiency and promote innovation
of targeted therapies |
| October 12, 2018 - FDA
advances investigation into whether more than 40 e-cigarette products
are being illegally marketed and outside agency's compliance policy |
| October 11, 2018 - FDA
approves new DNA-based test to determine blood compatibility |
| October 09, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance
the development of generic copies of complex drugs to improve patient
access to medicines |
| October 05, 2018 - La
FDA aprueba el uso ampliado de Gardasil 9 para incluir a personas
de 27 a 45 años de edad |
|
October 05, 2018 - FDA
approves expanded use of Gardasil 9 to include individuals 27 through
45 years old
|
| October 05, 2018 - FDA
allows marketing of first self-fitting hearing aid controlled by the
user |
| October 02, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new agency actions
to further deter ‘gaming’ of the generic drug approval process
by the use of citizen petitions |
|
October 01, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on FDA’s efforts
to strengthen the agency’s medical device cybersecurity program
as part of its mission to protect patients
|
| September 28, 2018 - FDA
approves a new antibacterial drug to treat a serious lung disease
using a novel pathway to spur innovation |
| September 28, 2018 - FDA
authorizes first next generation sequencing-based test to detect very
low levels of remaining cancer cells in patients with acute lymphoblastic
leukemia or multiple myeloma |
| September 28, 2018 - FDA
approves first treatment for advanced form of the second most common
skin cancer |
| September 27, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on modernizing standards
of identity and the use of dairy names for plant-based substitutes |
| September 27, 2018 - Statement
by FDA Commissioner Scott Gottlieb, M.D., on preparations for the
upcoming flu season and vaccinations |
| September 26, 2018 -
Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment
to disclose retailer information for certain food recalls to improve
consumer safety |
| September 25, 2018 - Remarks
from Anna Abram as prepared for delivery to the 2018 Intergovermental
Meeting on Drug Compounding |
| September 24, 2018 - FDA
awards 12 grants to fund new clinical trials to advance the development
of medical products for the treatment of rare diseases |
| September 18, 2018 - FDA
takes important steps to encourage appropriate and rational prescribing
of opioids through final approval of new safety measures governing
the use of immediate-release opioid analgesic medications |
| September 18, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s ongoing
efforts to prevent foodborne outbreaks of Cyclospora |
| September 18, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on launch of ‘The
Real Cost’ Youth E-Cigarette Prevention Campaign amid evidence
of sharply rising use among kids |
| September 18, 2018 - FDA
launches new, comprehensive campaign to warn kids about the dangers
of e-cigarette use as part of agency’s Youth Tobacco Prevention
Plan, amid evidence of sharply rising use among kids |
| September 14, 2018 - FDA
approves device for treatment of acute coronary artery perforations |
| September 14, 2018 - Statement
from Binita Ashar, M.D., of the FDA’s Center for Devices and
Radiological Health on agency’s commitment to studying breast
implant safety |
| September 13, 2018 - FDA
provides update on its ongoing investigation into valsartan products;
and reports on the finding of an additional impurity identified in
one firm’s already recalled products |
| September 13, 2018 - FDA
approves new kind of treatment for hairy cell leukemia |
| September 12, 2018 - FDA
awards five grants to advance the development of pediatric medical
devices |
| September 12, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., and Center for Devices
and Radiological Health Director Jeff Shuren, M.D., J.D., on agency
efforts to work with tech industry to spur innovation in digital health |
| September 12, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new steps to address
epidemic of youth e-cigarette use |
| September 12, 2018 - FDA
takes new steps to address epidemic of youth e-cigarette use, including
a historic action against more than 1,300 retailers and 5 major manufacturers
for their roles perpetuating youth access |
| September 11, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new warning letters
FDA is issuing to companies marketing kratom with unproven medical
claims; and the agency’s ongoing concerns about kratom |
| September 10, 2018 - USDA
and FDA announce joint public meeting on use of animal cell culture
technology to develop products derived from livestock and poultry |
|
September 07, 2018 - FDA
approves new dosage strength of buprenorphine and naloxone sublingual
film as maintenance treatment for opioid dependence
|
| September 07, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new steps to help ensure
the quality of and preserve access to compounded drugs by pursuing
closer collaboration with states |
| September 06, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on an updated approach
for including added sugar information on the Nutrition Facts labels
of pure maple syrup and honey |
| September 05, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the agency’s global
efforts to help assure product quality and transparency at foreign
drug manufacturing facilities |
| August 31, 2018 - La
FDA ayuda a facilitar el comercio entre los socios comerciales estadounidenses
y extranjeros con un nuevo programa de certificación de exportaciones
para los alimentos |
| August 31, 2018 - FDA
announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals
due to incorrect drug in bottles |
| August 31, 2018 - FDA
helps facilitate trade between U.S. and foreign trading partners with
new export certification program for food |
| August 30, 2018 - District
Court orders permanent injunction against companies selling sexual
enhancement products containing undisclosed drugs |
| August 30, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D.,
director of the Center for Drug Evaluation and Research on FDA’s
ongoing investigation into valsartan impurities and recalls and an
update on FDA’s current findings |
| August 29, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on FDA’s support
for exempting coffee from California’s cancer warning law |
| August 29, 2018 - Statement
by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing
work to forcefully address the opioid crisis |
| August 28, 2018 - FDA
alerts consumers, pet owners not to use products manufactured by King
Bio, including Dr. King’s label, homeopathic drug and pet products |
| August 28, 2018 - FDA
takes action against 21 websites marketing unapproved opioids as part
of agency’s effort to target illegal online sales |
| August 23, 2018 - Companies
cease sales of e-liquids with labeling or advertising that resembled
kid-friendly foods following FDA, FTC warnings |
| August 22, 2018 - FDA
approves first drug for neurotrophic keratitis, a rare eye disease |
| August 22, 2018 - Statement
by FDA Commissioner Scott Gottlieb, M.D., on new steps to advance
the development of evidence-based, indication-specific guidelines
to help guide appropriate prescribing of opioid analgesics |
| August 17, 2018 - FDA
permits marketing of transcranial magnetic stimulation for treatment
of obsessive compulsive disorder |
| August 16, 2018 - FDA
approves first generic version of EpiPen |
| August 16, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on advancing the science
and regulation of live microbiome-based products used to prevent,
treat, or cure diseases in humans |
| August 16, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on significant public
health value and cost savings resulting from the agency’s youth
smoking prevention campaign |
| August 15, 2018 - Statement
by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new resource
guide to support responsible opioid prescribing for pain management
in animals |
| August 10, 2018 - FDA
approves new treatment for a rare genetic disorder, Fabry disease |
| August 10, 2018 - FDA
approves new vaginal ring for one year of birth control |
| August 10, 2018 - FDA
approves first-of-its kind targeted RNA-based therapy to treat a rare
disease |
| August 10, 2018 - FDA
allows marketing of first direct-to-consumer app for contraceptive
use to prevent pregnancy |
| August 08, 2018 - FDA
approves treatment for two rare types of non-Hodgkin lymphoma |
| August 08, 2018 - FDA
approves first generic drug under new pathway aimed at enhancing market
competition for sole source drugs |
| August 08, 2018 - FDA
alerts healthcare providers, women about risks associated with improper
use of rupture of membranes tests |
| August 06, 2018 - FDA
takes new steps to encourage the development of novel medicines for
the treatment of opioid use disorder |
|
August 03, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new steps the agency
is taking to support the development of novel nicotine replacement
drug therapies to help smokers quit cigarettes
|
|
August 01, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on FDA’s continued,
careful oversight of the REMS associated with transmucosal immediate-release
fentanyl products
|
| July 31, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts
to advance antimicrobial stewardship in veterinary settings |
| July 30, 2018 - FDA
approves first treatment for rare adrenal tumors |
| July 30, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard
women’s health from deceptive health claims and significant risks
related to devices marketed for use in medical procedures for “vaginal
rejuvenation” |
| July 26, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the process FDA is
undertaking for reviewing and modernizing the agency’s standards
of identity for dairy products |
| July 24, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on voluntary recalls of
Ritz, Goldfish and other products issued out of an abundance of caution |
| July 24, 2018 - FDA
approves magnetic device system for guiding sentinel lymph node biopsies
in certain patients with breast cancer |
| July 23, 2018 - FDA
continues taking key actions on bulk drug substances used for compounding
to advance the regulatory framework governing compounded drugs and
to protect patients |
| July 20, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement
to halt Essure sales in the U.S.; agency’s continued commitment
to postmarket review of Essure and keeping women informed |
| July 20, 2018 - FDA
approves first targeted treatment for patients with relapsed or refractory
acute myeloid leukemia who have a certain genetic mutation |
| July 20, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts
to encourage the development of and broaden access to generic versions
of opioid analgesics that are formulated to deter abuse |
| July 19, 2018 - Statement
from FDA warning about significant health risks of contaminated illegal
synthetic cannabinoid products that are being encountered by FDA |
| July 19, 2018 - Statement
by FDA Commissioner Scott Gottlieb, M.D., on the formation of a new
work group to develop focused drug importation policy options to address
access challenges related to certain sole-source medicines with limited
patient availability, but no blocking patents or exclusivities |
| July 18, 2018 - Remarks
from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery
at the Brookings Institution on the release of the FDA’s Biosimilars
Action Plan |
| July 18, 2018 - FDA
approves first cancer drug through new oncology review pilot that
enables greater development efficiency |
| July 17, 2018 - New
York-based food processors agree to stop food preparation operations
due to food safety violations |
| July 17, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on new efforts to empower
consumers by advancing access to nonprescription drugs |
| July 13, 2018 - FDA
announces voluntary recall of several medicines containing valsartan
following detection of an impurity |
| July 13, 2018 - FDA
approves the first drug with an indication for treatment of smallpox |
| July 13, 2018 - FDA
warns of imposters sending consumers fake warning letters |
| July 12, 2018 - Statement
by FDA Commissioner Scott Gottlieb, M.D., on formation of a new drug
shortages task force and FDA’s efforts to advance long-term solutions
to prevent shortages |
| July 12, 2018 - FDA
expands its support for states to advance implementation of produce
safety activities |
| July 11, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on agency’s efforts
to advance development of gene therapies |
| July 10, 2018 - Federal
judge enters consent decree against Minnesota dairy farm for drug
residue violations |
| July 10, 2018 - FDA
updates warnings for fluoroquinolone antibiotics on risks of mental
health and low blood sugar adverse reactions |
| July 10, 2018 - FDA
takes action to support American military personnel by granting an
authorization for freeze-dried plasma product to enable broader access
while the agency works toward approval of the product |
| July 09, 2018 - Statement
by FDA Commissioner Scott Gottlieb, M.D., on balancing access to appropriate
treatment for patients with chronic and end-of-life pain with need
to take steps to stem misuse and abuse of opioids |
| July 02, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner
for Foods and Veterinary Medicine Stephen Ostroff, M.D., on the ongoing
risk of salmonella in kratom product |
| June 29, 2018 - FDA
approves novel device for treating breathing difficulty from severe
emphysema |
| June 28, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts
to collaborate with internet stakeholders to stop the illegal sale
of opioids online |
| June 28, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued
efforts relating to compounded drugs for patients who cannot use an
FDA-approved drug |
| June 28, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on developments in the
romaine outbreak investigation, recent outbreaks and the use of modern
tools to advance food safety |
| June 26, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps
to advance health through improvements in nutrition under the agency’s
Nutrition Innovation Strategy |
| June 25, 2018 - Statement
by FDA Commissioner Scott Gottlieb, M.D., on the importance of conducting
proper research to prove safe and effective medical uses for the active
chemicals in marijuana and its components |
| June 25, 2018 - FDA
approves first drug comprised of an active ingredient derived from
marijuana to treat rare, severe forms of epilepsy |
| June 22, 2018 - FDA
permits marketing of first catheter-based systems used to create vascular
access for hemodialysis patients |
| June 21, 2018 - FDA
approves automated insulin delivery and monitoring system for use
in younger pediatric patients |
| June 21, 2018 - FDA
approves first continuous glucose monitoring system with a fully implantable
glucose sensor and compatible mobile app for adults with diabetes |
| June 19, 2018 - Statement
from Douglas Throckmorton, M.D., deputy center director for regulatory
programs in FDA’s Center for Drug Evaluation and Research, on
the agency’s response to ongoing drug shortages for critical
products |
| June 19, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help
manufacturers implement protections against potential attacks on the
U.S. food supply |
| June 15, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner
Anna Abram on emerging food innovation, “cultured” food
products |
| June 14, 2018 -
FDA approves first generic versions of Suboxone sublingual film, which
may increase access to treatment for opioid dependence |
| June 14, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts
to better equip consumers with nutritional information about dietary
fiber in their food |
| June 12, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts
to advance the patient voice in medical product development and FDA
regulatory decision-making |
| June 12, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts
to foster discovery and development of new tools to fight antimicrobial-resistant
infections |
| June 12, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance
medical product communications to support drug competition and value-based
health care |
|
June 08, 2018 - Federal
judge enters consent decree against Delta Pharma
|
| June 07, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth
Tobacco Survey results and ongoing FDA efforts to protect youth from
the dangers of nicotine and tobacco products |
| June 06, 2018 - FDA
seeks permanent injunction against company selling unapproved hand
sanitizers that claim to prevent infections from numerous pathogens |
| June 06, 2018 - FDA
Deputy Commissioner for Policy, Planning, Legislation, and Analysis
Anna Abram, remarks prepared for testimony before a subcommittee of
the U.S. House Committee on Energy and Commerce on the Pandemic and
All-Hazards Preparedness Act |
| June 05, 2018 - FDA
and USDA announce key step to advance collaborative efforts to streamline
produce safety requirements for farmers |
| June 05, 2018 - FDA
takes action against 53 websites marketing unapproved opioids as part
of a comprehensive effort to target illegal online sales |
| June 05, 2018 - FDA
warns companies to stop selling dangerous and illegal pure and highly
concentrated caffeine products |
| June 04, 2018 - FDA
approves first biosimilar to Neulasta to help reduce the risk of infection
during cancer treatment |
|
June 04, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on proposed modernization
of FDA’s drug review office
|
| May 31, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on FDA’s work to
mitigate shortages of intravenous drugs, shorten supply disruptions
and better predict vulnerabilities |
| May 31, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new policies to reduce
the ability of brand drug makers to use REMS programs as a way to
block timely generic drug entry, helping promote competition and access |
| May 30, 2018 - FDA
approves first artificial iris |
| May 30, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness
and FDA’s response efforts to the Ebola virus outbreak in the
Democratic Republic of Congo |
| May 30, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the signing of the
Right to Try Act |
| May 30, 2018 - FDA
approves new treatment for moderately to severely active ulcerative
colitis |
| May 30, 2018 - As
part of efforts to combat opioid crisis, FDA launches innovation challenge
to spur development of medical devices - including digital health
and diagnostics - that target pain, addiction and diversion |
| May 24, 2018 - FDA
approves a new treatment for PKU, a rare and serious genetic disease |
| May 24, 2018 - FDA
permits marketing of artificial intelligence algorithm for aiding
providers in detecting wrist fractures |
| May 23, 2018 - FDA
takes action against the use of OTC benzocaine teething products due
to serious safety risk, lack of benefit |
| May 22, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to
keep consumers safe from the harmful effects of sun exposure, and
ensure the long-term safety and benefits of sunscreens |
| May 22, 2018 - FDA
warns companies selling illegal, unapproved kratom products marketed
for opioid cessation, pain treatment and other medical uses |
| May 21, 2018 - FDA
approves new drug for patients with chronic liver disease who have
low blood platelets and are undergoing a medical procedure |
| May 17, 2018 - FDA
approves novel preventive treatment for migraine |
| May 17, 2018 - FDA
requires additional e-cigarette makers to provide critical information
so the agency can better examine youth use and product appeal, amid
continued concerns around youth access to products |
| May 17, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts
to shine light on situations where drug makers may be pursuing gaming
tactics to delay generic competition |
| May 16, 2018 - FDA
approves the first non-opioid treatment for management of opioid withdrawal
symptoms in adults |
| May 15, 2018 - FDA
approves first epoetin alfa biosimilar for the treatment of anemia |
| May 11, 2018 - FDA
expands approval of Gilenya to treat multiple sclerosis in pediatric
patients |
| May 11, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s
plan to lower drug prices |
| May 10, 2018 - FDA
warns more companies to stop misleading kids with e-liquids that resemble
kid-friendly foods as part of Youth Tobacco Prevention Plan |
| May 09, 2018 - FDA
seeks permanent injunctions against two stem cell clinics |
| May 07, 2018 - FDA
permits marketing of new endoscopic device for treating gastrointestinal
bleeding |
| May 07, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the public health benefits
from enactment of menu labeling |
|
May 04, 2018 - FDA
approves new uses for two drugs administered together for the treatment
of BRAF-positive anaplastic thyroid cancer
|
|
May 01, 2018 - FDA,
FTC take action against companies misleading kids with e-liquids
that resemble children’s juice boxes, candies and cookies
|
| April 24, 2018 - Remarks
from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony
before a U.S. Senate Committee on Appropriations on FDA’s Fiscal
Year 2019 budget |
| April 24, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new enforcement actions
and a Youth Tobacco Prevention Plan to stop youth use of, and access
to, JUUL and other e-cigarettes |
| April 20, 2018 - FDA
authorizes new use of test, first to identify the emerging pathogen
Candida auris |
| April 20, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new steps to encourage
more widespread innovation and development of new treatments for opioid
use disorder |
| April 20, 2018 - FDA
takes new steps to advance the development of innovative products
for treating opioid use disorder |
| April 19, 2018 - Federal
judge enters consent decree against Cantrell Drug Company |
| April 17, 2018 - Remarks
from FDA Commissioner Scott Gottlieb, M.D. on Fiscal Year 2019 budget
request for FDA |
| April 17, 2018 - FDA
approves first therapy for rare inherited form of rickets, x-linked
hypophosphatemia |
| April 17, 2018 - Statement
by Dr. Susan Mayne on FDA efforts to reduce consumer exposure to arsenic
in rice |
| April 17, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new efforts to enhance
and modernize the FDA’s approach to medical device safety and
innovation |
| April 13, 2018 - La
FDA toma medidas para proteger a los consumidores de los suplementos
alimenticios que contienen niveles peligrosamente altos de cafeína
altamente concentrada o pura |
| April 13, 2018 - FDA
takes step to protect consumers against dietary supplements containing
dangerously high levels of extremely concentrated or pure caffeine |
| April 12, 2018 - FDA
finalizes guidances to accelerate the development of reliable, beneficial
next generation sequencing-based tests |
| April 11, 2018 - FDA
permits marketing of artificial intelligence-based device to detect
certain diabetes-related eye problems |
| April 10, 2018 - FDA
clears first contact lens with light-adaptive technology |
| April 09, 2018 - FDA
restricts sale and distribution of Essure to protect women and to
require that patients receive risk information |
|
April 03, 2018 - FDA
orders mandatory recall for kratom products due to risk of salmonella
|
|
April 02, 2018 - New
York raw milk cheese company ordered to stop sales for food safety
violations
|
| March 30, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts
to enhance the patient perspective and experience in drug development
and review |
| March 29, 2018 - FDA
expands approval of Blincyto for treatment of a type of leukemia in
patients who have a certain risk factor for relapse |
| March 29, 2018 - Federal
judge approves consent decree with New York dietary supplement manufacturer
Riddhi USA |
| March 28, 2018 - Federal
judge approves consent decree with Florida company that sold unapproved
new drugs and misbranded drugs |
| March 27, 2018 - FDA
authorizes first fully interoperable continuous glucose monitoring
system, streamlines review pathway for similar devices |
| March 23, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing
FDA’s oversight of drug compounding and implementing new laws
governing outsourcing facilities |
| March 22, 2018 - Statement
from FDA’s Donald St. Pierre on findings from ongoing investigation
into lead testing issues |
| March 20, 2018 - FDA
expands approval of Adcetris for first-line treatment of Stage III
or IV classical Hodgkin lymphoma in combination with chemotherapy |
| March 20, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce tobacco
use, especially among youth, by exploring options to address the role
of flavors ? including menthol ? in tobacco products |
| March 15, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on pivotal public health
step to dramatically reduce smoking rates by lowering nicotine in
combustible cigarettes to minimally or non-addictive levels |
| March 09, 2018 - FDA
warns duodenoscope manufacturers about failure to comply with required
postmarket surveillance studies to assess contamination risk |
| March 08, 2018 - Remarks
from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony
before the U.S. House Committee on Energy and Commerce Subcommittee
on Oversight and Investigations hearing “Examining U.S. Public
Health Preparedness for and Response Efforts to Seasonal Influenza.” |
| March 08, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on effort to help bolster
U.S. shellfish market by taking mutually beneficial steps to resume
shellfish trade with the EU |
| March 07, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on FDA activities related
to the ongoing post-market review of Essure and FDA’s commitment
to keep women informed |
| March 06, 2018 - FDA
approves first tests to screen for tickborne parasite in whole blood
and plasma to protect the U.S. blood supply |
| March 06, 2018 - FDA
expands approval of replacement heart valve, smallest mechanical valve
size approved in the world |
| March 06, 2018 - FDA
approves new HIV treatment for patients who have limited treatment
options |
| March 06, 2018 - FDA
authorizes, with special controls, direct-to-consumer test that reports
three mutations in the BRCA breast cancer genes |
| March 05, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on FDA’s commitment
to modernizing food and nutrition programs |
|
March 02, 2018 - FDA
warns of fraudulent and unapproved flu products
|
| March 01, 2018 - FDA
alerts health care professionals and patients not to use compounded
drugs from Cantrell Drug Company; agency seeks action to stop production
and distribution |
|
March 01, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts
to advance implementation of the new consumer Nutrition Facts label
for foods
|
| February 26, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on FDA’s ongoing
efforts to help improve effectiveness of influenza vaccines |
| February 23, 2018 - Statement
from Stephen Ostroff M.D., Deputy Commissioner for Foods and Veterinary
Medicine, on National Toxicology Program draft report on Bisphenol
A |
| February 21, 2018 - FDA
oversees destruction and recall of kratom products; and reiterates
its concerns on risks associated with this opioid |
| February 16, 2018 - FDA
expands approval of Imfinzi to reduce the risk of non-small cell lung
cancer progressing |
| February 15, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on the efficacy of the
2017-2018 influenza vaccine |
| February 15, 2018 - FDA
expands treatment window for use of clot retrieval devices in certain
stroke patients |
| February 15, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on advancing the development
of novel treatments for neurological conditions; part of broader effort
on modernizing FDA’s new drug review programs |
| February 14, 2018 - FDA
approves new treatment for a certain type of prostate cancer using
novel clinical trial endpoint |
| February 14, 2018 - FDA
authorizes marketing of first blood test to aid in the evaluation
of concussion in adults |
| February 13, 2018 - FDA
permits marketing of clinical decision support software for alerting
providers of a potential stroke in patients |
| February 13, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on Administration’s
request for new FDA funding to promote innovation and broaden patient
access through competition |
| February 08, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on groundbreaking approval
and interagency approach to bring stable supply of critical medical
imaging isotope to the U.S. |
| February 08, 2018 - FDA
and NRC pave way for the first domestic supply of the most commonly
used medical isotope in diagnostic imaging |
| February 06, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific
evidence on the presence of opioid compounds in kratom, underscoring
its potential for abuse |
| February 02, 2018 - Statement
from Jeffrey Shuren, M.D., J.D., director of the FDA’s Center
for Devices and Radiological Health on the recent National Toxicology
Program draft report on radiofrequency energy exposure |
| February 01, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to
mitigate impact of saline shortages during this flu season |
| January 30, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent
new addiction, curb abuse and overdose related to opioid products |
| January 30, 2018 - FDA,
USDA announce formal agreement to bolster coordination and collaboration |
| January 26, 2018 - FDA
approves new treatment for certain digestive tract cancers |
| January 26, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on FDA’s strengthened
commitments to humane and judicious animal research and the termination
of a nicotine study |
| January 24, 2018 - FDA,
FTC warn companies for selling illegal, unapproved opioid cessation
products using deceptive claims |
| January 18, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new policy steps for
strengthening public warning and notification of recalls |
| January 16, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report
regarding FDA’s ongoing commitment to employing a least burdensome
approach to device review |
| January 16, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D. responding to report from
GAO and updating on FDA’s ongoing efforts to increase access
to complex generic drugs |
| January 16, 2018 - FDA
Commissioner Scott Gottlieb, M.D., updates on some ongoing shortages
related to IV fluids |
| January 16, 2018 - FDA
and DoD launch program to expedite availability of medical products
for the emergency care of American military personnel |
| January 16, 2018 - FDA
Commissioner Scott Gottlieb, M.D., on new steps FDA is taking to enhance
transparency of clinical trial information to support innovation and
scientific inquiry related to new drugs |
| January 12, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on FDA decision to seek
additional time to reassess rule that would have changed longstanding
practices for how the agency determined the ?intended use’ of
medical products |
| January 12, 2018 - FDA
approves first treatment for breast cancer with a certain inherited
genetic mutation |
| January 11, 2018 - FDA
warns Becton Dickinson & Company of significant violations of
the law as part of ongoing investigation into lead testing issues |
| January 11, 2018 - FDA
acts to protect kids from serious risks of opioid ingredients contained
in some prescription cough and cold products by revising labeling
to limit pediatric use |
| January 04, 2018 - Statement
by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts
in Puerto Rico, and continued efforts to mitigate IV saline and amino
acid drug shortages |
| January 04, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on FDA Food Safety Modernization
Act enforcement discretion guidance |
| January 04, 2018 - FDA
warns American CryoStem Corporation of significant deviations related
to its unapproved stem cell product, Atcell |
| January 03, 2018 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate
efficient generic drug review to enhance competition, promote access
and lower drug prices |
See the current
MedSun newsletter at the FDA website for Recalls and Safety Alerts,
Highlighted Reports, and Links to FDA/CDRH Databases and Other Information
Sources.
|
|
