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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.
| September 30, 2016 - FDA
warns against the use of homeopathic teething tablets and gels |
| September 29, 2016 - FDA
Statement from Todd Simpson, FDA Chief Information Officer (CIO) on
GAO Report Regarding FDA’s IT Security Program |
| September 28, 2016 - FDA
approves first automated insulin delivery device for type 1 diabetes |
| September 23, 2016 - FDA
approves expanded indications for Ilaris for three rare diseases |
| September 23, 2016 - FDA
approves Amjevita, a biosimilar to Humira |
| September 19, 2016 - FDA
launches competition to spur innovative technologies to help reduce
opioid overdose deaths |
| September 19, 2016 - FDA
grants accelerated approval to first drug for Duchenne muscular dystrophy |
| September 16, 2016 - FDA
permits marketing of balloon device to treat persistent Eustachian
tube dysfunction |
| September 15, 2016 - FDA
protects kids from illegal sales of e-cigarettes, e-liquids and cigars |
| September 13, 2016 - FDA
approves VisuMax Femtosecond Laser to surgically treat nearsightedness |
| September 09, 2016 - FDA
provides $21.8 million to states for FSMA produce safety rule implementation |
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September 02, 2016 - FDA
allows marketing of clot retrieval devices to reduce disability
in stroke patients
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September 02, 2016 - FDA
issues final rule on safety and effectiveness of antibacterial soaps
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| August 31, 2016 - FDA
requires strong warnings for opioid analgesics, prescription opioid
cough products, and benzodiazepine labeling related to serious risks
and death from combined use |
| August 30, 2016 - FDA
approves Erelzi, a biosimilar to Enbrel |
| August 26, 2016 - FDA
advises testing for Zika virus in all donated blood and blood components
in the US |
| August 22, 2016 - FDA
Statement on Medical Device User Fee Agreement (MDUFA) |
| August 22, 2016 - FDA
allows marketing of first-of-kind computerized cognitive tests to
help assess cognitive skills after a head injury |
| August 18, 2016 - FDA
approves expanded indication for two transcatheter heart valves for
patients at intermediate risk for death or complications associated
with open-heart surgery |
| August 11, 2016 - FDA
updates draft guidance on premarket safety notifications for dietary
supplement industry |
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August 05, 2016 - FDA
issues draft updated recommendations on submitting a new 510(k)
for device modifications
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August 04, 2016 - Kratom
seized in California by US Marshals Service
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| July 28, 2016 - Statement
from Peter Marks, M.D., Ph.D., Director, FDA’s Center for Biologics
Evaluation and Research |
| July 28, 2016 - FDA
approves Adlyxin to treat type 2 diabetes |
| July 26, 2016 - FDA
updates warnings for fluoroquinolone antibiotics |
| July 19, 2016 - Federal
court orders Minnesota sprout and noodle company to cease operations
due to unsanitary conditions |
| July 15, 2016 - FDA
approves first intraocular lens with extended range of vision for
cataract patients |
| July 12, 2016 - FDA
approves new medication for dry eye disease |
| July 11, 2016 - FDA
approves first MRI-guided focused ultrasound device to treat essential
tremor |
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July 08, 2016 - FDA
approves Differin Gel 0.1% for over-the-counter use to treat acne
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| July 07, 2016 - FDA
approves first HPV test for use with SurePath Preservative Fluid |
| July 06, 2016 - FDA
advances Precision Medicine Initiative by issuing draft guidances
on next generation sequencing-based tests |
| July 06, 2016 - Federal
court orders Alabama seafood company to cease production due to food
safety violations |
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July 05, 2016 - FDA
approves first absorbable stent for coronary artery disease
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| June 29, 2016 - FDA
clears first test to detect specific genetic markers for certain antibiotic-resistant
bacteria directly from clinical specimens |
| June 29, 2016 - FDA
approves implantable device that changes the shape of the cornea to
correct near vision |
| June 29, 2016 - FDA
requests additional information to address data gaps for consumer
hand sanitizers |
| June 29, 2016 - Statement
from FDA Commissioner Robert Califf, M.D. announcing the acting director
of the FDA Oncology Center of Excellence |
| June 28, 2016 - FDA
approves Epclusa for treatment of chronic Hepatitis C virus infection |
| June 28, 2016 - Federal
Court orders California soy company to cease production due to food
safety violations |
| June 14, 2016 - FDA
approves AspireAssist obesity device |
| June 10, 2016 - FDA
approves vaccine to prevent cholera for travelers |
| June 09, 2016 - FDA
targets unlawful internet sales of illegal prescription medicines
during International Operation Pangea IX |
| June 09, 2016 - Statement
on HHS OIG Early Alert on FDA food recall initiation process |
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June 02, 2016 - Statement
from FDA Commissioner Robert Califf, M.D. on the release of the
final individual patient expanded access form
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| June 01, 2016 - FDA
approves new diagnostic imaging agent to detect rare neuroendocrine
tumors |
| June 01, 2016 - FDA
approves first blood test to detect gene mutation associated with
non-small cell lung cancer |
| June 01, 2016 - FDA
takes action against Kansas food manufacturer for repeated food safety
violations |
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June 01, 2016 - FDA
issues draft guidance to food industry for voluntarily reducing
sodium in processed and commercially prepared food
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| May 31, 2016 - FDA
approves Ocaliva for rare, chronic liver disease |
| May 27, 2016 -
FDA approves Zinbryta to treat multiple sclerosis |
| May 27, 2016 - FDA
approves new diagnostic imaging agent to detect recurrent prostate
cancer |
| May 26, 2016 - FDA
approves first buprenorphine implant for treatment of opioid dependence |
| May 26, 2016 - FDA
issues final food defense regulation |
| May 20, 2016 - FDA
modernizes Nutrition Facts label for packaged foods |
| May 18, 2016 - FDA
approves new, targeted treatment for bladder cancer |
| May 10, 2016 - FDA
issues rule for data collection of antimicrobial sales and distribution
by animal species |
| May 05, 2016 - FDA
reminds health care professionals not to use drug products intended
to be sterile from Medaus |
| May 05, 2016 - FDA
takes significant steps to protect Americans from dangers of tobacco
through new regulation |
| May 03, 2016 - Federal
court orders rice noodle company to stop selling products until it
complies with food safety regulations |
| May 02, 2016 - FDA
launches public education campaign to prevent and reduce tobacco use
among LGBT young adults |
| English |
| April 29, 2016 - Federal
judge enters order of permanent injunction against Paul W. Franck |
| April 22, 2016 - FDA
proposes ban on electrical stimulation devices intended to treat self-injurious
or aggressive behavior |
| April 19, 2016 - FDA
launches first ad campaign focused on dangers of smokeless tobacco
among rural teens |
| April 14, 2016 - FDA
approves folic acid fortification of corn masa flour |
| April 11, 2016 - FDA
approves new drug for chronic lymphocytic leukemia in patients with
a specific chromosomal abnormality |
| April 08, 2016 - FDA
takes steps to withdraw approval of the swine drug carbadox due to
safety concerns |
| April 07, 2016 - FDA
allows marketing of first-of-kind tissue containment system for use
with certain laparoscopic power morcellators in select patients |
| April 06, 2016 - FDA
approves first leadless pacemaker to treat heart rhythm disorders |
| April 05, 2016 - FDA
approves Inflectra, a biosimilar to Remicade |
| April 05, 2016 - FDA
releases final rule to ensure food safety during transport |
| April 01, 2016 - FDA
proposes limit for inorganic arsenic in infant rice cereal |
| English |
| March 30, 2016 - FDA
approves first treatment for rare disease in patients who receive
stem cell transplant from blood or bone marrow |
| March 30, 2016 - FDA
allows use of investigational test to screen blood donations for Zika
virus |
| March 24, 2016 - FDA
takes important step to increase the development of, and access to,
abuse-deterrent opioids |
| March 23, 2016 - FDA
approves Cinqair to treat severe asthma |
| March 22, 2016 - FDA
approves new psoriasis drug Taltz |
| March 22, 2016 - FDA
announces enhanced warnings for immediate-release opioid pain medications
related to risks of misuse, abuse, addiction, overdose and death |
| March 21, 2016 - FDA
proposes ban on most powdered medical gloves |
| March 21, 2016 - FDA
approves new treatment for inhalation anthrax |
| March 11, 2016 - FDA
expands use of Xalkori to treat rare form of advanced non-small cell
lung cancer |
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March 04, 2016 - FDA
permits marketing of device that senses optimal time to check patient’s
eye pressure
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| March 04, 2016 - FDA
approves first coagulation factor-albumin fusion protein to treat
patients with hemophilia B |
| March 03, 2016 - FDA
and DOJ take action against Virginia soybean business for selling
contaminated sprouts |
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March 01, 2016 - FDA
issues recommendations to reduce the risk of Zika virus transmission
by human cell and tissue products
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| English |
| February 29, 2016 - FDA
takes additional action to better understand safety of Essure, inform
patients of potential risks |
| February 29, 2016 - FDA
providing $2 million in new grants for natural history studies in
rare diseases |
| February 26, 2016 - Federal
judge approves consent decree with Florida dietary supplement distributor,
Viruxo |
| February 24, 2016 - FDA
Statement on Senate Confirmation of Dr. Robert M. Califf |
| February 19, 2016 - FDA
approves Briviact to treat partial onset seizures |
| February 16, 2016 - FDA
issues recommendations to reduce the risk for Zika virus blood transmission
in the United States |
| February 16, 2016 - Maine
smoked fish company agrees to halt production of adulterated fish |
| February 09, 2016 - FDA
seeks $5.1 billion total for FY 2017, including funds to implement
food safety law, improve medical product safety and quality |
| February 04, 2016 - Califf,
FDA top officials call for sweeping review of agency opioids policies |
| English |
| January 28, 2016 - FDA
approves Zepatier for treatment of chronic hepatitis C genotypes 1
and 4 |
| January 28, 2016 - FDA
approves first drug to show survival benefit in liposarcoma |
| January 22, 2016 - FDA
resolves criminal and civil actions against cheese manufacturer |
| January 15, 2016 - FDA
outlines cybersecurity recommendations for medical device manufacturers |
| January 15, 2016 - FDA
clears Olympus TJF-Q180V duodenoscope with design modifications intended
to reduce infection risk |
| January 11, 2016 - Federal
judge enters consent decree against Downing Labs |
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January 07, 2016 - FDA
approves Integra Omnigraft Dermal Regeneration Matrix to treat diabetic
foot ulcers
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| January 06, 2016 - US
Marshals seize dietary supplements containing kratom |
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January 06, 2016 - The
FDA engages stakeholders on opportunities to improve hearing aid
usage and innovation
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January 04, 2016 - FDA
strengthens requirements for surgical mesh for the transvaginal
repair of pelvic organ prolapse to address safety risks
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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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