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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 23, 2019 - FDA
approves first generics of Eliquis |
| December 23, 2019 - FDA
approves new treatment for adults with migraine |
| December 20, 2019 - FDA
approves new treatment option for patients with HER2-positive breast
cancer who have progressed on available therapies |
| December 20, 2019 - FDA,
DEA seize 44 websites advertising sale of illicit THC vaping cartridges
to US consumers as part of Operation Vapor Lock |
| December 19, 2019 - FDA
takes efforts to improve quality of compounded drugs from outsourcing
facilities through collaboration and education as part of new Center
of Excellence |
| December 19, 2019 - Statement
on National Academies of Sciences, Engineering, and Medicine report
on framing opioid prescribing guidelines for acute pain |
| December 19, 2019 - First
FDA-approved vaccine for the prevention of Ebola virus disease, marking
a critical milestone in public health preparedness and response |
| December 18, 2019 - FDA
approves new type of therapy to treat advanced urothelial cancer |
| December 18, 2019 - Trump
Administration takes historic steps to lower U.S. prescription drug
prices |
| December 17, 2019 - Statement
on low-cost biosimilar and interchangeable protein products |
| December 17, 2019 - FDA
permits sale of two new reduced nicotine cigarettes through premarket
tobacco product application pathway |
| December 13, 2019 - FDA
approves use of drug to reduce risk of cardiovascular events in certain
adult patient groups |
| December 13, 2019 - FDA
clears first fully disposable duodenoscope, eliminating the potential
for infections caused by ineffective reprocessing |
| December 13, 2019 - FDA
authorizes first interoperable, automated insulin dosing controller
designed to allow more choices for patients looking to customize their
individual diabetes management device system |
| December 12, 2019 - FDA
grants accelerated approval to first targeted treatment for rare Duchenne
muscular dystrophy mutation |
| December 12, 2019 - Statement
on new findings and current status of the romaine lettuce E. coli
O157:H7 outbreak investigation |
| December 12, 2019 - FDA
authorizes first test to aid in newborn screening for Duchenne Muscular
Dystrophy |
| December 11, 2019 - FDA
issues warning letter for not including the most serious risks in
advertisement for medication-assisted treatment drug |
| December 10, 2019 - FDA
underscores that consumers should not use drugs, dietary supplements
and devices recalled from Basic Reset and Biogenyx following consent
decree for federal violations |
| December 6, 2019 - FDA
sends warning to companies for offering unapproved umbilical cord
blood products that may put patients at risk |
| December 5, 2019 - Statement
from Janet Woodcock, M.D., director of FDA’s Center for Drug
Evaluation and Research, on impurities found in diabetes drugs outside
the U.S. |
| December 5, 2019 - FDA
approves first generics of Gilenya |
| December 5, 2019 - FDA
authorizes marketing of diagnostic test that uses novel technology
to detect MRSA bacteria |
| December 5, 2019 - FDA
launches app for health care professionals to report novel uses of
existing medicines for patients with difficult-to-treat infectious
diseases |
| November 27, 2019 - FDA
orders Puerto Rico fertility clinic to cease manufacturing immediately
for significant violations that pose a danger to health |
| November 26, 2019 - California-based
food manufacturer agrees to stop production after repeated food safety
violations |
| November 25, 2019 - FDA
approves system for the delivery of ear tubes under local anesthesia
to treat ear infection |
| November 25, 2019 - FDA
warns 15 companies for illegally selling various products containing
cannabidiol as agency details safety concerns |
| November 25, 2019 - FDA
approves novel treatment to target abnormality in sickle cell disease |
| November 25, 2019 - Statement
on efforts to help make development of biosimilar and interchangeable
insulin products more efficient |
| November 25, 2019 - Statement
on new steps to advance innovation in medical device sterilization
with ethylene oxide |
| November 21, 2019 - FDA
approves new treatment for adults with partial-onset seizures |
| November 21, 2019 - FDA
takes second action under international collaboration, approves new
treatment option for patients with chronic lymphocytic leukemia |
| November 20, 2019 - FDA
approves first treatment for inherited rare disease |
| November 15, 2019 - Statement
from Sarah Yim, M.D., acting director of the Office of Therapeutic
Biologics and Biosimilars in the FDA’s Center for Drug Evaluation
and Research, on FDA’s continued progress facilitating competition
in the biologic marketplace with approval of 25th biosimilar product |
| November 15, 2019 - FDA
approves first contact lens indicated to slow the progression of nearsightedness
in children |
| November 15, 2019 - FDA
approves first targeted therapy to treat patients with painful complication
of sickle cell disease |
| November 15, 2019 - FDA
clears first duodenoscope with disposable elevator piece, reducing
the number of parts needing disinfection |
| November 14, 2019 - FDA
approves new antibacterial drug to treat complicated urinary tract
infections as part of ongoing efforts to address antimicrobial resistance |
| November 14, 2019 - FDA
approves therapy to treat patients with relapsed and refractory mantle
cell lymphoma supported by clinical trial results showing high response
rate of tumor shrinkage |
| November 14, 2019 - FDA
issues warning letter to Dollar Tree stores for receiving potentially
unsafe drugs |
| November 8, 2019 - FDA
approves first therapy to treat patients with rare blood disorder |
| November 6, 2019 - Statement
on the agency’s efforts to protect patients through postmarket
drug safety surveillance practices |
| November 5, 2019 - FDA
authorizes marketing of first next-generation sequencing test for
detecting HIV-1 drug resistance mutations |
| November 1, 2019 - Statement
on new testing results, including low levels of impurities in ranitidine
drugs |
| October 30, 2019 - USDA,
EPA and FDA announce partnership with the Food Waste Reduction Alliance |
| October 29, 2019 - Digital
submission of adverse event reports for investigational new drug applications
reflects FDA’s ongoing modernization efforts |
| October 29, 2019 - Statement
on FDA’s new report regarding root causes and potential solutions
to drug shortages |
| October 25, 2019 - Statement
on concerns with medical device availability due to certain sterilization
facility closures |
| October 24, 2019 - Statement
on agency’s first year accomplishments implementing SUPPORT Act
authorities to address the opioids crisis |
| October 24, 2019 - Statement
on the agency’s efforts to protect patients from potentially
harmful drugs sold as homeopathic products |
| October 23, 2019 - Statement
on the agency’s continued efforts to protect women’s health
and enhance safety information available to patients considering breast
implants |
| October 22, 2019 - FDA
grants first-ever modified risk orders to eight smokeless tobacco
products |
| October 21, 2019 - FDA
approves new breakthrough therapy for cystic fibrosis |
| October 18, 2019 - Baby
powder manufacturer voluntarily recalls products for asbestos |
| October 16, 2019 - Statement
on continued progress enhancing patient access to high-quality, low-cost
generic drugs |
| October 11, 2019 - FDA
approves new treatment for patients with migraine |
| October 10, 2019 - FDA
allows marketing of first rapid diagnostic test for detecting Ebola
virus antigens |
| October 8, 2019 - FDA
approves first treatment to increase pain-free light exposure in patients
with a rare disorder |
| October 8, 2019 - FDA
awards two grants for natural history studies in rare diseases |
| October 8, 2019 - FDA
awards 12 grants to fund new clinical trials to advance the development
of medical products for the treatment of rare diseases |
| October 4, 2019 - Statement
on consumer warning to stop using THC vaping products amid ongoing
investigation into lung illnesses |
| October 3, 2019 - FDA
approves second drug to prevent HIV infection as part of ongoing efforts
to end the HIV epidemic |
| October 1, 2019 - FDA
informs patients, providers and manufacturers about potential cybersecurity
vulnerabilities for connected medical devices and health care networks
that use certain communication software |
| September 30, 2019 - Statement
on measuring the progress being made through implementing the FDA
Food Safety Modernization Act |
| September 30, 2019 - FDA
and DEA warn website operators illegally selling opioids |
| September 30, 2019 - Statement
on continued efforts to evaluate materials in medical devices to address
potential safety questions |
| September 27, 2019 - FDA
approves first treatment for children with rare diseases that cause
inflammation of small blood vessels |
| September 26, 2019 - FDA
approves treatment for adults and children with all genotypes of hepatitis
C and compensated cirrhosis that shortens duration of treatment to
eight weeks |
| September 26, 2019 - Statement
on new steps to advance digital health policies that encourage innovation
and enable efficient and modern regulatory oversight |
| September 25, 2019 - Remarks
prepared for testimony before a U.S. House Energy and Commerce Subcommittee
on FDA Regulation of Electronic Nicotine Delivery Systems and Investigation
of Vaping Illnesses |
| September 24, 2019 -
FDA announces voluntary recall of Sandoz ranitidine capsules following
detection of an impurity |
| September 24, 2019 - FDA
approves first live, non-replicating vaccine to prevent smallpox and
monkeypox |
| September 23, 2019 - Statement
on FDA efforts to encourage patient engagement in medical device clinical
investigations |
| September 23, 2019 - Statement
on final guidance to help advance development of novel treatments
for ALS |
| September 20, 2019 - Statement
on continued efforts to increase availability of all forms of naloxone
to help reduce opioid overdose deaths |
| September 20, 2019 - FDA
approves first oral GLP-1 treatment for type 2 diabetes |
| September 20, 2019 - FDA
issues proposed rule for premarket tobacco product applications as
part of commitment to continuing strong oversight of e-cigarettes
and other tobacco products |
| September 19, 2019 - FDA
continues to take steps to fulfill its commitment to strengthen and
modernize the 510(k) medical device program |
| September 17, 2019 - FDA
takes first action under new international collaboration with Australia
and Canada designed to provide a framework for concurrent review of
cancer therapies, approving treatment for patients with endometrial
carcinoma |
| September 13, 2019 - Statement
alerting patients and health care professionals of NDMA found in samples
of ranitidine |
| September 11, 2019 - Trump
Administration Combating Epidemic of Youth E-Cigarette Use with Plan
to Clear Market of Unauthorized, Non-Tobacco-Flavored E-Cigarette
Products |
| September 9, 2019 - Statement
on improving adverse event reporting of compounded drugs to protect
patients |
| September 9, 2019 - FDA
warns JUUL Labs for marketing unauthorized modified risk tobacco products,
including in outreach to youth |
| September 6, 2019 - FDA
approves first treatment for patients with rare type of lung disease |
| September 3, 2019 - Federal
judge enters consent decree against Tennessee drug, dietary supplement
and device distributors, Basic Reset and Biogenyx, for drug, device
and dietary supplement violations |
| September 3, 2019 - FDA
sends warning to company for selling unapproved umbilical cord blood
and umbilical cord products that may put patients at risk; continues
to warn patients of the risk of unapproved stem cell therapy |
| August 30, 2019 - Statement
on federal and state collaboration to investigate respiratory illnesses
reported after use of e-cigarette products |
| August 29, 2019 - FDA
recommends health care facilities and manufacturers begin transitioning
to duodenoscopes with disposable components to reduce risk of patient
infection |
| August 28, 2019 - Statement
on the agency’s ongoing efforts to resolve safety issue with
ARB medications |
| August 27, 2019 - FDA
approves new add-on drug to treat off episodes in adults with Parkinson’s
disease |
| August 27, 2019 - FDA
requests recall of sterile compounded drug products produced by Pacifico
National Inc., dba AmEx Pharmacy, reminds patients and health care
professionals to stop using due to potential risks |
| August 26, 2019 - Statement
calling on all sectors of the papaya industry to improve practices
to better protect consumers |
| August 20, 2019 - FDA
warns company for putting consumers at risk with drug manufacturing
data integrity violations |
| August 20, 2019 - Statement
on new results demonstrating continued success of the agency’s
youth smoking prevention efforts and significant public health cost
savings |
| August 19, 2019 - FDA
approves new antibiotic to treat community-acquired bacterial pneumonia |
| August 16, 2019 - FDA
approves new device to improve symptoms in patients with advanced
heart failure |
| August 16, 2019 - FDA
expands indication for several transcatheter heart valves to patients
at low risk for death or major complications associated with open-heart
surgery |
| August 16, 2019 - FDA
approves first of its kind device to treat pediatric patients with
progressive idiopathic scoliosis |
| August 16, 2019 - FDA
approves treatment for patients with rare bone marrow disorder |
| August 15, 2019 - FDA
approves third oncology drug that targets a key genetic driver of
cancer, rather than a specific type of tumor |
| August 15, 2019 - FDA
proposes new required health warnings with color images for cigarette
packages and advertisements to promote greater public understanding
of negative health consequences of smoking |
| August 14, 2019 - FDA
approves new drug for treatment-resistant forms of tuberculosis that
affects the lungs |
| August 12, 2019 - FDA
warns consumers about the dangerous and potentially life threating
side effects of Miracle Mineral Solution |
| August 8, 2019 - FDA
notifies four companies to remove 44 flavored e-liquid and hookah
tobacco products from the market for not having required marketing
authorization |
| August 6, 2019 - Statement
on data accuracy issues with recently approved gene therapy |
| August 6, 2019 - FDA
statement on court ruling related to compounded bulk drug substances
and the agency’s ongoing efforts to implement its compounding
authorities |
| August 2, 2019 - FDA
approves first therapy for rare joint tumor |
| July 29, 2019 - FDA
clears new indications for existing Lyme disease tests that may help
streamline diagnoses |
| July 24, 2019 - FDA
approves first treatment for severe hypoglycemia that can be administered
without an injection |
| July 24, 2019 - FDA
takes action to protect patients from risk of certain textured breast
implants; requests Allergan voluntarily recall certain breast implants
and tissue expanders from market |
| July 23, 2019 - FDA
warns company marketing unapproved cannabidiol products with unsubstantiated
claims to treat cancer, Alzheimer’s disease, opioid withdrawal,
pain and pet anxiety |
| July 22, 2019 - FDA
suspends facility registration of Texas-based seafood producer after
significant, repeated food safety violations |
| July 22, 2019 - FDA
approves first generics of Lyrica |
| July 22, 2019 - FDA
launches its first youth e-cigarette prevention TV ads, plans new
educational resources as agency approaches one-year anniversary of
public education campaign |
| July 18, 2019 - Federal
judge enters consent decree against Arkansas food and medical product
grocery warehouse for insanitary conditions |
| July 17, 2019 - FDA
approves new treatment for complicated urinary tract and complicated
intra-abdominal infections |
| July 15, 2019 - Statement
on the agency’s actions to tackle the epidemic of youth vaping
and court ruling on application submission deadlines for certain tobacco
products, including e-cigarettes |
|
July 3, 2019 - FDA
approves new treatment for refractory multiple myeloma
|
| July 2, 2019 - FDA
warns repackers distributing pharmaceutical ingredients, including
opioids, for putting consumers at risk with significant violations
of manufacturing quality standards |
| July 1, 2019 - Statement
on steps to make health care professional and patient labeling information
for prescription medications consistent and clear |
| June 27, 2019 - FDA
warns patients and health care providers about potential cybersecurity
concerns with certain Medtronic insulin pumps |
| June 27, 2019 - FDA
approves first treatment for neuromyelitis optica spectrum disorder,
a rare autoimmune disease of the central nervous system |
| June 27, 2019 - FDA
issues third status report on investigation into potential connection
between certain diets and cases of canine heart disease |
| June 26, 2019 - FDA
approves first treatment for chronic rhinosinusitis with nasal polyps |
| June 25, 2019 - Statement
on stem cell clinic permanent injunction and FDA’s ongoing efforts
to protect patients from risks of unapproved products |
| June 25, 2019 - FDA
issues warnings to companies selling illegal, unapproved kratom drug
products marketed for opioid cessation, pain treatment and other medical
uses |
| June 21, 2019 - FDA
approves new treatment for hypoactive sexual desire disorder in premenopausal
women |
| June 21, 2019 - FDA
expands approval of treatment for cystic fibrosis to include patients
ages 6 and older |
| June 21, 2019 - Statement
on agency’s efforts to increase transparency in medical device
reporting |
| June 20, 2019 - Statement
on the FDA’s benefit-risk framework for evaluating opioid analgesics |
| June 18, 2019 - Statement
on a new effort to improve transparency and predictability for generic
drug applicants to help increase timely access to high-quality, lower
cost generic drugs |
| June 18, 2019 - Statement
on new guidance for the declaration of added sugars on food labels
for single-ingredient sugars and syrups and certain cranberry products |
| June 17, 2019 - FDA
approves new treatment for pediatric patients with type 2 diabetes |
| June 14, 2019 - Federal
officials seize adulterated dietary supplements from Life Rising Corporation
due to poor manufacturing practices |
| June 11, 2019 - Statement
on FDA’s scientific work to understand per- and polyfluoroalkyl
substances (PFAS) in food, and findings from recent FDA surveys |
| June 11, 2019 - FDA
finalizes guidance for premarket tobacco product applications for
electronic nicotine delivery systems as part of commitment to continuing
a strong oversight of e-cigarettes |
| June 10, 2019 - FDA
approves first chemoimmunotherapy regimen for patients with relapsed
or refractory diffuse large B-cell lymphoma |
| June 7, 2019 - FDA
permits marketing of first medical device for relief of pain associated
with irritable bowel syndrome in patients 11-18 years of age |
| June 7, 2019 - Remarks
on World Food Safety Day: ‘Food Safety Is Everyone’s Business’ |
| June 7, 2019 - FDA,
FTC take action to protect kids by citing four firms that make, sell
flavored e-liquids for violations related to online posts by social
media influencers on their behalf |
| June 4, 2019 - FDA
approves first treatment for episodic cluster headache that reduces
the frequency of attacks |
| June 4, 2019 - Federal
court issues decision holding that US Stem Cell clinics and owner
adulterated and misbranded stem cell products in violation of the
law |
| June 3, 2019 - FDA
approves new treatment for hospital-acquired and ventilator-associated
bacterial pneumonia |
| June 3, 2019 - Statement
on warning for women of childbearing age about possible safety risks
of dietary supplements containing vinpocetine |
| June 3, 2019 - FDA
announces Project Facilitate to assist physicians seeking access to
unapproved therapies for patients with cancer |
| May 30, 2019 - FDA
puts company on notice for marketing unapproved stem cell products
for treating serious conditions |
| May 30, 2019 - Statement
on FDA’s request for information on requiring fixed-quantity
blister packaging for certain opioid pain medicines to help decrease
unnecessary exposure to opioids |
| May 24, 2019 - FDA
approves first PI3K inhibitor for breast cancer |
| May 24, 2019 - FDA
approves innovative gene therapy to treat pediatric patients with
spinal muscular atrophy, a rare disease and leading genetic cause
of infant mortality |
| May 23, 2019 - FDA
permits marketing of first diagnostic test to aid in detecting prosthetic
joint infections |
| May 23, 2019 - FDA
authorizes marketing of first diagnostic test for detecting Zika virus
antibodies |
| May 23, 2019 - FDA
alerts hospitals, laboratories and health care professionals about
recall of Beckman Coulter blood test analyzers due to risk of inaccurate
platelet analyzing results |
| May 23, 2019 - FDA
clears first diagnostic tests for extragenital testing for chlamydia
and gonorrhea |
| May 22, 2019 - Federal
judge enters consent decree against compounder PharMedium Services
for violations at multiple facilities |
| May 22, 2019 - Federal
court enters consent decree against Texas compounder, Pharm D Solutions,
LLC to cease the manufacturing of drugs intended to be sterile due
to insanitary conditions |
| May 17, 2019 -
FDA Warns Against the Use of Unauthorized Devices for Diabetes Management |
| May 16, 2019 - FDA
approves first anticoagulant (blood thinner) for pediatric patients
to treat potentially life-threatening blood clots |
| May 14, 2019 - FDA
warns manufacturers of products labeled as homeopathic for putting
consumers at risk with significant violations of manufacturing quality
standards |
| May 10, 2019 - Statement
from Acting FDA Commissioner Ned Sharpless, M.D., on policy advancements
to help bring interchangeable biosimilars to market |
| May 8, 2019 - Statement
from Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and
Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation
and Research, on policies designed to capture more data to better
understand effects of prescription drugs in pregnant and nursing women |
| May 6, 2019 - FDA
approves first treatment for children with Lambert-Eaton myasthenic
syndrome, a rare autoimmune disorder |
| May 6, 2019 - FDA
approves new treatments for heart disease caused by a serious rare
disease, transthyretin mediated amyloidosis |
| May 2, 2019 - Statement
from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D.,
and Jeff Shuren, M.D., J.D., director of the FDA’s Center for
Devices and Radiological Health on FDA’s new efforts to protect
women’s health and help to ensure the safety of breast implants |
| May 1, 2019 - First
FDA-approved vaccine for the prevention of dengue disease in endemic
regions |
| April 30, 2019 - FDA
permits sale of IQOS Tobacco Heating System through premarket tobacco
product application pathway |
| April 30, 2019 - FDA
approves first treatment for all genotypes of hepatitis C in pediatric
patients |
| April 30, 2019 - FDA
requires stronger warnings about rare but serious incidents related
to certain prescription insomnia medicines |
| April 30, 2019 - Statement
from Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner
Frank Yiannas on steps to usher the U.S. into a new era of smarter
food safety |
| April 26, 2019 - FDA
approves device to help increase access to more lungs for transplant |
| April 26, 2019 - FDA
approves first treatment for pediatric patients with lupus |
| April 25, 2019 - FDA
launches public education campaign to encourage safe removal of unused
opioid pain medicines from homes |
| April 23, 2019 - Statement
from FDA Associate Commissioner for Regulatory Affairs Melinda K.
Plaisier, on agency’s new steps to strengthen the process of
initiating voluntary recalls |
| April 23, 2019 - Statement
from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center
for Devices and Radiological Health, on new steps to help reduce risks
associated with surgical staplers for internal use and implantable
staples |
| April 22, 2019 - Statement
from Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics
Evaluation and Research, on FDA’s continued confidence in the
safety and effectiveness of the measles, mumps, and rubella (MMR)
vaccine |
| April 19, 2019 - FDA
permits marketing of first medical device for treatment of ADHD |
| April 19, 2019 - FDA
approves first generic naloxone nasal spray to treat opioid overdose |
| April 16, 2019 - FDA
Statement from Deputy Commissioner for Food Policy and Response Frank
Yiannas on new steps to protect consumers from unlawful ingredients
in dietary supplements |
| April 16, 2019 - FDA
takes action to protect women’s health, orders manufacturers
of surgical mesh intended for transvaginal repair of pelvic organ
prolapse to stop selling all devices |
| April 12, 2019 - Statement
from Jeff Shuren, M.D., director of the Center for Devices and Radiological
Health, on agency efforts to mitigate temporary shortage of pediatric
breathing tubes due to recent closure of Illinois sterilization facility |
| April 12, 2019 - FDA
approves first targeted therapy for metastatic bladder cancer |
| April 12, 2019 - Statement
from Jeff Shuren, M.D., Director of the Center for Devices and Radiological
Health, on continued efforts to assess duodenoscope contamination
risk |
| April 11, 2019 - FDA
orders important safety labeling changes for Addyi |
| April 11, 2019 - FDA
issues final rule on safety and effectiveness of consumer hand sanitizers |
| April 10, 2019 - FDA
warns public not to use unapproved or uncleared medical devices to
help assess or diagnose a concussion |
| April 09, 2019 - USDA,
EPA, and FDA Unveil Strategy to Reduce Food Waste |
| April 09, 2019 - FDA
approves new treatment for osteoporosis in postmenopausal women at
high risk of fracture |
| April 09, 2019 - Statement
by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory
Programs in FDA’s Center for Drug Evaluation and Research, on
new opioid analgesic labeling changes to give providers better information
for how to properly taper patients who are physically dependent on
opioids |
| April 08, 2019 - FDA
approves first two-drug complete regimen for HIV-infected patients
who have never received antiretroviral treatment |
| April 08, 2019 - FDA
warns about risks of using home use test strips that are pre-owned
or not authorized for sale in U.S., including those for glucose, warfarin |
|
April 04, 2019 - FDA
issues warning letter to genomics lab for illegally marketing genetic
test that claims to predict patients’ responses to specific
medications
|
| April 04, 2019 - FDA
expands approved use of metastatic breast cancer treatment to include
male patients |
| April 04, 2019 - FDA
and CBP bolster collaboration to protect public health and safety |
| April 04, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D.,
director of the Center for Drug Evaluation and Research on the agency’s
list of known nitrosamine-free valsartan and ARB class medicines,
as part of agency’s ongoing efforts to resolve ongoing safety
issue |
| April 03, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner
Anna Abram on new 2019 efforts to improve the quality of compounded
drugs |
| April 03, 2019 - FDA
takes new steps to increase access to adverse event report data for
medical products used in animals |
| April 03, 2019 - Statement
by FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director
Peter Marks, M.D., Ph.D. on FDA’s continued efforts to stop stem
cell clinics and manufacturers from marketing unapproved products
that put patients at risk, while progressing the agency’s commitment
to help advance legitimate stem cell product development under existing
agency regulations |
| April 03, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., and Principal Deputy Commissioner
Amy Abernethy, M.D., Ph.D., on FDA’s ongoing scientific investigation
of potential safety issue related to seizures reported following e-cigarette
use, particularly in youth and young adults |
| April 02, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new,
tailored review framework for artificial intelligence-based medical
devices |
| April 02, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance
agency’s continued evaluation of potential regulatory pathways
for cannabis-containing and cannabis-derived products |
| April 02, 2019 - USDA,
EPA, and FDA Recognize April as Winning on Reducing Food Waste Month |
| April 02, 2019 - FDA
takes new enforcement actions as part of the agency’s ongoing
effort to combat the illegal online sales of opioids |
| April 02, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued
efforts to bring competition to the insulin market to lower prices
and expand access |
| April 01, 2019 - FDA
warns homeopathic firms for putting patients at risk with significant
violations of manufacturing quality standards |
|
April 01, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance
treatment strategies for helping youth addicted to nicotine as a
result of the epidemic rise in teen use of e-cigarettes
|
| March 29, 2019 - FDA
approves new oral treatment for multiple sclerosis |
| March 29, 2019 - Statement
by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center
for Drug Evaluation and Research Janet Woodcock, M.D. and Director
of FDA’s Center for Biologics Evaluation and Research Peter Marks,
M.D. on Expanded Access –Looking Forward |
| March 28, 2019 -
FDA approves treatment for patients with a type of inflammatory arthritis |
| March 28, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on actions to advance
our comprehensive plan to reduce tobacco-related disease and death,
through new efforts to improve the tobacco product application review
process, including a newly proposed rule |
| March 28, 2019 - Remarks
from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony
before a U.S. Senate Subcommittee on Appropriations on FDA’s
Fiscal Year 2020 budget |
| March 27, 2019 - FDA
approves new oral testosterone capsule for treatment of men with certain
forms of hypogonadism |
| March 27, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen
agency’s safety requirements aimed at mitigating risks associated
with transmucosal immediate-release fentanyl products |
| March 27, 2019 - FDA
advances landmark policy changes to modernize mammography services
and improve their quality |
| March 26, 2019 - FDA
approves new oral drug to treat multiple sclerosis |
| March 26, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is
taking to prevent potential medical device shortages and ensure safe
and effective sterilization amid shutdown of a large contract sterilization
facility |
| March 26, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s
Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D.,
on efforts to promote and foster blood pathogen reduction technologies |
| March 21, 2019 - FDA
approves new device for treating moderate to severe chronic heart
failure in patients |
| March 19, 2019 - FDA
approves first treatment for post-partum depression |
| March 19, 2019 - FDA
issues warning letters to two breast implant manufacturers for failure
to comply with post-approval study requirements |
| March 19, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner
Frank Yiannas on new steps to strengthen FDA’s food safety program
for 2020 and beyond |
| March 19, 2019 - FDA
takes action against marketer of unapproved products claiming to treat
addiction, chronic pain and other serious conditions |
| March 15, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D.,
Director of the Center for Devices and Radiological Health, on efforts
to evaluate materials in medical devices to address potential safety
questions |
| March 15, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner
Frank Yiannas on advancing new tools and science for implementing
agricultural water requirements for produce safety |
| March 14, 2019 - FDA
allows marketing of new device to help treat carbon monoxide poisoning |
| March 14, 2019 - Statement
by FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize
clinical trials to advance precision medicine, patient protections
and more efficient product development |
| March 14, 2019 - FDA
approves new indication for valve repair device to treat certain heart
failure patients with mitral regurgitation |
| March 13, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on advancing new policies
aimed at preventing youth access to, and appeal of, flavored tobacco
products, including e-cigarettes and cigars |
| March 12, 2019 - FDA
approves a new generic valsartan |
| March 12, 2019 - Federal
judge enters consent decree against Texas compounder, Guardian Pharmacy
Services |
| March 11, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on Administration’s
request for new FDA funding to continue to advance robust regulatory
framework for oversight of e-cigarettes, prevent youth access and
initiation; and harness innovation to advance the safety of food,
compounded drugs, U.S. blood supply |
|
March 08, 2019 - FDA
takes steps to help reduce risks associated with surgical staplers
and implantable staples
|
| March 08, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on continued efforts to
advance safe biotechnology innovations, and the deactivation of an
import alert on genetically engineered salmon |
| March 07, 2019 - USDA
and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food
Products from Cell Lines of Livestock and Poultry |
| March 07, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on FDA’s steps on
naming of biological medicines to balance competition and safety for
patients receiving these products |
| March 05, 2019 - FDA
approves new nasal spray medication for treatment-resistant depression;
available only at a certified doctor’s office or clinic |
| March 05, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D.,
director of the Center for Food Safety and Applied Nutrition, on tests
confirming a 2017 finding of asbestos contamination in certain cosmetic
products and new steps that FDA is pursuing to improve cosmetics safety |
| March 04, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions
focused on retailers, manufacturers to combat youth access to e-cigarettes
as part of FDA’s Youth Tobacco Prevention Plan |
|
March 01, 2019 - FDA
provides update on its ongoing investigation into ARB drug products;
reports on finding of a new nitrosamine impurity in certain lots
of losartan and product recall
|
| February 28, 2019 - FDA
warns CanaRx for selling unapproved, misbranded and unsafe imported
drugs to unsuspecting Americans |
| February 27, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D. as prepared for oral testimony
before the U.S. House Subcommittee on Agriculture, Rural Development,
Food and Drug Administration, and Related Agencies, Committee on Appropriations |
| February 26, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on the agency’s 2019
policy and regulatory agenda for continued action to forcefully address
the tragic epidemic of opioid abuse |
| February 26, 2019 - FDA,
CDC, and CMS launch task force to help facilitate rapid availability
of diagnostic tests during public health emergencies |
| February 26, 2019 - 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
modern approach to advanced pharmaceutical manufacturing |
| February 25, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner
Frank Yiannas on a new strategy to advance FDA’s food safety
mission and modernize oversight of imported food |
| February 25, 2019 - FDA
issues warning letter to clinic illegally marketing unapproved thermography
device, warns consumers to avoid using thermography devices to detect
breast cancer |
| February 22, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on efforts to spur development
of innovative devices, including new advancements in novel brain implants,
that can help patients with paralysis or amputation gain mobility |
| February 22, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s
Center for Drug Evaluation and Research Janet Woodcock, M.D., on the
FDA’s continuing efforts to maintain its strong oversight of
generic drug quality issues domestically and abroad |
| February 21, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on additional steps by
the agency to support the development of safe and effective novel
nicotine replacement therapies to help smokers quit cigarettes |
| February 21, 2019 - FDA
advances new proposed regulation to make sure that sunscreens are
safe and effective |
| February 19, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s
Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D.,
cautioning consumers against receiving young donor plasma infusions
that are promoted as unproven treatment for varying conditions |
| February 15, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve
access and foster price competition for drugs that face inadequate
generic competition |
| February 14, 2019 -
FDA authorizes first interoperable insulin pump intended to allow
patients to customize treatment through their individual diabetes
management devices |
| February 14, 2019 - FDA
issues warning letter to doctor for illegally marketing unapproved
device with claims to prevent and treat tightening of scar tissue
around breast implants |
| February 13, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner
Frank Yiannas on findings from the agency’s investigation of
the November 2018 outbreak of E. coli O157:H7 in California-linked
romaine lettuce |
| February 13, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on new programs to promote
the adoption of innovations in drug manufacturing that can improve
quality and lower drug costs |
| February 12, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to
stop the spread of illicit opioids, further secure the U.S. drug supply
chain and forcefully confront opioid epidemic |
| February 11, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating
rising youth use of tobacco products and the agency’s ongoing
actions to confront the epidemic of youth e-cigarette use |
| February 11, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new
efforts to strengthen regulation of dietary supplements by modernizing
and reforming FDA’s oversight |
| February 11, 2019 - FDA
takes action against 17 companies for illegally selling products claiming
to treat Alzheimer’s disease |
| February 07, 2019 -
FDA
takes new steps to adopt more modern technologies for improving the
security of the drug supply chain through innovations that improve
tracking and tracing of medicines |
| February 07, 2019 - FDA
pursues order barring specific retailers from selling tobacco products
as part of its continuing efforts to target youth tobacco use |
| February 07, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen
the agency’s process for issuing public warnings and notifications
of recalls |
| February 06, 2019 - Statement
from Binita Ashar, M.D., of the FDA’s Center for Devices and
Radiological Health on agency’s continuing efforts to educate
patients on known risk of lymphoma from breast implants |
| February 06, 2019 - Federal
court enters consent decree against Ranier’s Rx Laboratory and
owner for manufacturing purportedly sterile drug products in insanitary
conditions |
| February 06, 2019 - FDA
approves first therapy for the treatment of adult patients with a
rare blood clotting disorder |
| February 01, 2019 - FDA
warns patients and doctors about recall of home-use test strips used
with device to monitor blood thinner warfarin, not authorized for
sale in U.S. |
| January 30, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on 2019 efforts to advance
the development of complex generics to improve patient access to medicines |
| January 30, 2019 - FDA
approves first generic Advair Diskus |
| January 30, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts
to enhance the utility of the Orange Book to foster drug competition |
| January 28, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D.,
Director of the Center for Devices and Radiological Health, on a record
year for device innovation |
| January 25, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D.,
director of the Center for Drug Evaluation and Research on the FDA’s
ongoing investigation into valsartan and ARB class impurities and
the agency’s steps to address the root causes of the safety issues |
| January 24, 2019 - FDA
statement from Commissioner Scott Gottlieb, M.D. announcing efforts
to improve the quality of the information used to assess the effectiveness
of REMS programs in supporting the safe use of medications |
| January 23, 2019 - FDA
permits marketing of first test to aid in the diagnosis of a sexually-transmitted
infection known as Mycoplasma genitalium |
| January 22, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D.,
Director of the Center for Devices and Radiological Health, on latest
steps to strengthen FDA’s 510(k) program for premarket review
of medical devices |
| January 17, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on unprecedented new efforts
to support development of over-the-counter naloxone to help reduce
opioid overdose deaths |
| January 16, 2019 - FDA
approves first generic version of Sabril to help treat seizures in
adults and pediatric patients with epilepsy |
| January 15, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D. and Peter Marks, M.D.,
Ph.D., Director of the Center for Biologics Evaluation and Research
on new policies to advance development of safe and effective cell
and gene therapies |
| January 07, 2019 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new
actions under the Pre-Cert Pilot Program to promote a more efficient
framework for the review of safe and effective digital health innovations |
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.
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