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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 28, 2017 - FDA
permits marketing of device to treat diabetic foot ulcers |
| December 26, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on efforts to support more
efficient and effective food recalls |
| December 22, 2017 - FDA
updates the label of Tasigna to reflect that certain patients with
a type of leukemia may be eligible to stop treatment after sustained
response |
| December 22, 2017 - FDA
clears stereotactic radiotherapy system for use in treating breast
cancer |
| December 21, 2017 - FDA
approves drug to treat dangerously low blood pressure |
| December 19, 2017 - FDA
approves novel gene therapy to treat patients with a rare form of
inherited vision loss |
| December 18, 2017 - FDA
proposes new, risk-based enforcement priorities to protect consumers
from potentially harmful, unproven homeopathic drugs |
| December 15, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new FDA efforts to
support more efficient development of targeted therapies |
| December 13, 2017 - FDA
launches new tool for sharing information that allows doctors to better
manage antibiotic use; improve patient care |
| December 12, 2017 - FDA
approves first drug for Eosinophilic Granulomatosis with Polyangiitis,
a rare disease formerly known as the Churg-Strauss Syndrome |
| December 12, 2017 - FDA
warns companies for promoting alternatives to street drugs |
| December 11, 2017 - FDA
approves Admelog, the first short-acting "follow-on" insulin
product to treat diabetes |
| December 11, 2017 - FDA
launches public education campaign to encourage adult smokers trying
to quit cigarettes |
| December 07, 2017 - Remarks
from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony
before the U.S. Senate Committee on Health, Education, Labor &
Pensions Hearing, “Implementation of the 21st Century Cures Act:
Progress and the Path Forward for Medical Innovation |
| December 07, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital
health policies to encourage innovation, bring efficiency and modernization
to regulation |
| December 04, 2017 - Statement
by FDA Commissioner Scott Gottlieb, M.D., on FDA ushering in new era
of 3D printing of medical products; provides guidance to manufacturers
of medical devices |
| December 01, 2017 - FDA
approves first biosimilar for the treatment of certain breast and
stomach cancers |
| November 30, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the approval of a new
formulation of buprenorphine and FDA’s efforts to promote more
widespread innovation and access to opioid addiction treatments |
| November 30, 2017 - FDA
approves first once-monthly buprenorphine injection, a medication-assisted
treatment option for opioid use disorder |
| November 30, 2017 - Statement
by FDA Commissioner Scott Gottlieb, M.D., updating on Puerto Rico
related medical product shortages |
| November 30, 2017 - FDA
announces approval, CMS proposes coverage of first breakthrough-designated
test to detect extensive number of cancer biomarkers |
| November 30, 2017 - Remarks
from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony
before the House Committee on Energy and Commerce Hearing, “Implementing
the 21st Century Cures Act: An Update from FDA and NIH" |
| November 22, 2017 - FDA
approves first implanted lens that can be adjusted after cataract
surgery to improve vision without eyeglasses in some patients |
| November 21, 2017 - FDA
approves first two-drug regimen for certain patients with HIV |
| November 21, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development
of generic versions of opioids formulated to deter abuse |
| November 17, 2017 - FDA
approves first telehealth option to program cochlear implants remotely |
| November 17, 2017 - Statement
by FDA Commissioner Scott Gottlieb, M.D., on efforts to address impact
of IV fluid shortages following hurricane destruction and resolve
manufacturing shortfalls |
| November 16, 2017 - FDA
expands approval of Sutent to reduce the risk of kidney cancer returning |
| November 16, 2017 - FDA
approves new treatment to prevent bleeding in certain patients with
hemophilia A |
| November 16, 2017 - FDA
announces comprehensive regenerative medicine policy framework |
| November 16, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on FDA’s comprehensive
new policy approach to facilitating the development of innovative
regenerative medicine products to improve human health |
| November 15, 2017 - FDA
unveils a streamlined path for the authorization of tumor profiling
tests alongside its latest product action |
| November 15, 2017 - FDA
approves treatment for rare genetic enzyme disorder |
| November 15, 2017 - FDA
grants marketing authorization of the first device for use in helping
to reduce the symptoms of opioid withdrawal |
| November 14, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on FDA advisory about deadly
risks associated with kratom |
| November 14, 2017 - FDA
warns about illegal use of injectable silicone for body contouring
and associated health risks |
| November 13, 2017 - FDA
approves pill with sensor that digitally tracks if patients have ingested
their medication |
| November 08, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve
FDA review of shared Risk Evaluation and Mitigation Strategies to
improve generic drug access |
| November 07, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on a practical approach
to ensuring timely implementation of FDA’s menu labeling rule |
| November 06, 2017 - FDA
clears common blood cell count test that offers faster results for
patients and providers |
| November 06, 2017 - FDA
approves first treatment for certain patients with Erdheim-Chester
Disease, a rare blood cancer |
| November 06, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on implementation of agency’s
streamlined development and review pathway for consumer tests that
evaluate genetic health risks |
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November 01, 2017 - FDA
warns companies marketing unproven products, derived from marijuana,
that claim to treat or cure cancer
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November 01, 2017 - FDA
reaches agreement with automatic external defibrillator manufacturer
over quality control issues
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| October 31, 2017 - FDA
approves new treatment for adults with mantle cell lymphoma |
| October 31, 2017 - FDA
takes unprecedented step toward more efficient global pharmaceutical
manufacturing inspections |
| October 30, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new strategies for
addressing the crisis of opioid addiction through innovation in packaging,
storage and disposal |
| October 30, 2017 - Statement
from Susan Mayne, Ph.D., on proposal to revoke health claim that soy
protein reduces risk of heart disease |
| October 26, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s
important efforts to address the opioid crisis |
| October 25, 2017 - Remarks
from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony
before the House Committee on Energy and Commerce Hearing, “Federal
Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other
Initiatives |
| October 24, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance
medical device innovation and help patients gain faster access to
beneficial technologies |
| October 23, 2017 - FDA
warns Magellan Diagnostics of significant violations of the law as
part of investigation into lead testing issues |
| October 20, 2017 - Statement
by FDA Commissioner Scott Gottlieb, M.D. on medical device manufacturing
recovery in Puerto Rico |
| October 18, 2017 - FDA
approves CAR-T cell therapy to treat adults with certain types of
large B-cell lymphoma |
| October 13, 2017 - FDA
clears new robotically-assisted surgical device for adult patients |
| October 13, 2017 - California
dietary supplement maker, Custompax prohibited from manufacturing |
| October 13, 2017 - Statement
by FDA Commissioner Scott Gottlieb, M.D. on Baxter manufacturing recovery
in Puerto Rico |
| October 12, 2017 - FDA
clears first 7T magnetic resonance imaging device |
| October 11, 2017 - Statement
by FDA Commissioner Scott Gottlieb, M.D. on new steps by FDA to advance
patient engagement in the agency’s regulatory work |
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October 06, 2017 - FDA
approves implantable device to treat moderate to severe central
sleep apnea
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October 06, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on FDA’s continued
assistance following the natural disaster in Puerto Rico
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October 06, 2017 - FDA
awards six grants for natural history studies in rare diseases
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October 06, 2017 - FDA
awards 15 grants for clinical trials to stimulate product development
for rare diseases
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October 05, 2017 - FDA
approves first test for screening Zika virus in blood donations
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October 02, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s Adverse
Event Reporting System (FAERS) and new search tool
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| September 28, 2017 - FDA
improves access to reports of adverse drug reactions |
| September 28, 2017 - FDA
approves new treatment for certain advanced or metastatic breast cancers |
| September 27, 2017 - FDA
approves first continuous glucose monitoring system for adults not
requiring blood sample calibration |
| September 26, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on new efforts to encourage
compounding of better quality drugs under DQSA and help health care
professionals access compounded medications needed for patient care
from outsourcing facilities |
| September 26, 2017 - Federal
judge orders Flawless Beauty to stop distributing unapproved drugs,
recall certain products |
| September 26, 2017 - FDA
selects participants for new digital health software precertification
pilot program |
| September 25, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on FDA actions to bring
relief to citizens of Puerto Rico; to help the island recover its
considerable and economically vital medical product manufacturing
base; and to prevent critical shortages of life-saving drugs made
in Puerto Rico |
| September 25, 2017 - FDA
conducts major global operation to protect consumers from potentially
dangerous prescription drugs sold online |
| September 22, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on FDA’s immediate
steps to respond to Hurricane Maria and ongoing recovery efforts related
to Hurricanes Harvey and Irma |
| September 22, 2017 - Criminal
and civil actions filed against Aegerion Pharmaceuticals Inc. |
| September 20, 2017 - FDA
clears first duodenoscope with disposable distal cap |
| September 20, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued
efforts to promote the safe adoption of medication-assisted treatment
for opioid addiction |
| September 14, 2017 - FDA
approves new treatment for adults with relapsed follicular lymphoma |
| September 14, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., about crops impacted by
Hurricanes Harvey and Irma and FDA’s work with farmers affected
by the storms |
| September 14, 2017 - FDA
approves first biosimilar for the treatment of cancer |
| September 14, 2017 - FDA
permits marketing of mobile medical application for substance use
disorder |
| September 07, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health
claim advising that early introduction of peanuts to certain high-risk
infants may reduce risk of peanut allergy |
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September 01, 2017 - FDA
clears mammography device with option for patient-assisted compression
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September 01, 2017 - FDA
approves Mylotarg for treatment of acute myeloid leukemia
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| August 31, 2017 - Statement
from Center for Drug Evaluation and Research Director Janet Woodcock
regarding safety concerns related to investigational use of Keytruda
in multiple myeloma |
| August 30, 2017 - FDA
approval brings first gene therapy to the United States |
| August 29, 2017 - FDA
approves new antibacterial drug |
| August 29, 2017 - FDA
approves first U.S. treatment for Chagas disease |
| August 28, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s new policy
steps and enforcement efforts to ensure proper oversight of stem cell
therapies and regenerative medicine |
| August 28, 2017 - FDA
warns US Stem Cell Clinic of significant deviations |
| August 28, 2017 - FDA
acts to remove unproven, potentially harmful treatment used in ‘stem
cell’ centers targeting vulnerable patients |
| August 25, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s role
in ensuring Americans have access to clear and consistent calorie
and nutrition information; forthcoming guidance will provide greater
clarity and certainty |
| August 21, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D. – FDA is carefully
evaluating prescription opioid medications approved to treat cough
in children |
| August 17, 2017 - FDA
provides new tools for the development and proper evaluation of tests
for detecting Zika virus infection |
| August 17, 2017 - FDA
approves new treatment for adults with relapsed or refractory acute
lymphoblastic leukemia |
| August 11, 2017 - FDA
warns of potential contamination in multiple brands of drugs, dietary
supplements |
| August 08, 2017 - FDA
to expand public education campaign to focus on prevention of youth
e-cigarette use |
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August 04, 2017 - Federal
judge enters consent decree against outsourcing facility Isomeric
Pharmacy Solutions
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| August 03, 2017 - FDA
approves Mavyret for Hepatitis C |
| August 03, 2017 - FDA
approves first treatment for certain types of poor-prognosis acute
myeloid leukemia |
| August 02, 2017 - FDA
approves treatment for chronic graft versus host disease |
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August 01, 2017 - FDA
approves new targeted treatment for relapsed or refractory acute
myeloid leukemia
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| July 28, 2017 - FDA
announces comprehensive regulatory plan to shift trajectory of tobacco-related
disease, death |
| July 20, 2017 - FDA
clears first neonatal magnetic resonance imaging device |
| July 19, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the Funding Awards
to States for FDA Food Safety Modernization Act (FSMA) Produce Safety
Implementation |
| July 18, 2017 - FDA
approves Vosevi for Hepatitis C |
| July 17, 2017 - FDA
approves new treatment to reduce the risk of breast cancer returning |
| July 13, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on National Academies
of Sciences, Engineering, and Medicine report on pain management and
prescription opioid abuse |
| July 13, 2017 - Statement
from Alberto Gutierrez, Ph.D., Director, Office of In Vitro Diagnostics
and Radiological Health, FDA’s Center for Devices and Radiological
Health on the status of FDA’s investigation into inaccurate results
from certain lead tests |
| July 07, 2017 - FDA
approves new treatment for sickle cell disease |
| July 06, 2017 - Federal
judge enters consent decree against Alabama compounder Medistat |
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July 03, 2017 - FDA
clears expanded use of cooling cap to reduce hair loss during chemotherapy
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| June 30, 2017 - Federal
judge orders New York smoked fish company to stop sales due to food
safety violations |
| June 29, 2017 - FDA
allows marketing of test to aid in the detection of certain leukemias
and lymphomas |
| June 29, 2017 - FDA
unveils plan to eliminate orphan designation backlog |
| June 27, 2017 - FDA
Tackles Drug Competition to Improve Patient Access |
| June 26, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the importance of the
Drug Quality and Security Act and overseeing the safety of compounded
drugs |
| June 22, 2017 - FDA
approves first subcutaneous C1 Esterase Inhibitor to treat rare genetic
disease |
| June 20, 2017 - U.S.
Marshals seize adulterated food from a Minnesota warehouse |
| June 15, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D., on the 2016 National Youth
Tobacco Survey results |
| June 15, 2017 - Sonar
Products ordered to cease operations, Stratus Pharmaceuticals ordered
to cease distributing unapproved drugs |
| June 13, 2017 - Statement
from FDA Commissioner Scott Gottlieb, M.D. – FDA is taking new
steps to help assess opioid drugs with abuse-deterrent properties |
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June 08, 2017 - FDA
requests removal of Opana ER for risks related to abuse
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June 05, 2017 - FDA
expands use of Sapien 3 artificial heart valve for high-risk patients
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| April 28, 2017 - FDA
approves new combination treatment for acute myeloid leukemia |
| April 27, 2017 - FDA
approves first treatment for a form of Batten disease |
| April 27, 2017 - FDA
expands approved use of Stivarga to treat liver cancer |
| April 25, 2017 - FDA
takes action against 14 companies for selling illegal cancer treatments |
| April 20, 2017 - FDA
statement from Douglas Throckmorton, M.D., deputy center director
for regulatory programs, Center for Drug Evaluation and Research,
on new warnings about the use of codeine and tramadol in children
& nursing mothers |
| April 12, 2017 - FDA
allows marketing of first whole slide imaging system for digital pathology |
| April 11, 2017 - FDA
approves first drug to treat tardive dyskinesia |
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April 07, 2017 - FDA
approves two hepatitis C drugs for pediatric patients
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April 06, 2017 - FDA
allows marketing of first direct-to-consumer tests that provide
genetic risk information for certain conditions
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| March 31, 2017 - FDA
alerts consumers of nationwide voluntary recall of EpiPen and EpiPen
Jr |
| March 29, 2017 - FDA
approves new drug to treat multiple sclerosis |
| March 28, 2017 - FDA
approves new eczema drug Dupixent |
| March 27, 2017 - FDA
approves maintenance treatment for recurrent epithelial ovarian, fallopian
tube or primary peritoneal cancers |
| March 23, 2017 - FDA
approves first treatment for rare form of skin cancer |
| March 21, 2017 - FDA
approves drug to treat Parkinson’s disease |
| March 14, 2017 - Colorado
unapproved drug and dietary supplement makers ordered to cease operations
for federal violations |
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March 03, 2017 - FDA
approves first treatment for frequent urination at night due to
overproduction of urine
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| March 02, 2017 - Mutual
Recognition promises new framework for pharmaceutical inspections
for United States and European Union |
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March 01, 2017 - FDA
approves Odactra for house dust mite allergies
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| February 28, 2017 - FDA
approves Xermelo for carcinoid syndrome diarrhea |
| February 23, 2017 - FDA
clears test to help manage antibiotic treatment for lower respiratory
tract infections and sepsis |
| February 23, 2017 - FDA
allows marketing of test to identify organisms that cause bloodstream
infections and provide antibiotic sensitivity results |
| February 21, 2017 - Louisiana
drug and dietary supplement maker ordered to cease operations due
to federal violations |
| February 15, 2017 - FDA
approves new psoriasis drug |
| February 09, 2017 - FDA
approves drug to treat Duchenne muscular dystrophy |
| February 09, 2017 - Federal
judge approves consent decree with California dietary supplement distributor,
Regeneca Worldwide |
| February 03, 2017 - FDA
permits marketing of first newborn screening system for detection
of four, rare metabolic disorders |
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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