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Press releases from FDA
Updated: 29 min 32 sec ago

Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the regulation of cell-cultured food products from cell lines of livestock and poultry

Fri, 2018-11-16 15:43
The U.S. Department of Agriculture and U.S. Food and Drug Administration are announcing that USDA and FDA should jointly oversee the production of cell-cultured food products derived from livestock and poultry.

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

Fri, 2018-11-16 10:38
The FDA is committed to making sure post-market studies are transparent to the public and that industry is fulfilling their PMRs and PMCs.

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

Fri, 2018-11-16 10:11
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to reduce use of animals through a study aimed at eliminating the use of dogs in certain trials

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

Fri, 2018-11-16 09:40
The FDA expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.

Results from 2018 National Youth Tobacco Survey show dramatic increase in e-cigarette use among youth over past year

Thu, 2018-11-15 09:26
New findings from the National Youth Tobacco Survey show that more than 3.6 million middle and high school students were current (past 30 day) e-cigarette users in 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

Thu, 2018-11-15 09:07
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

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

Wed, 2018-11-14 10:18
FDA alerted health care providers and patients about the serious complications that can occur when using medications not approved for use with implanted pumps that deliver medication into the spinal fluid to treat or manage pain.

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

Tue, 2018-11-13 09:06
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

FDA seizes food and medical products held under insanitary conditions at an Arkansas grocery warehouse

Fri, 2018-11-09 14:51
U.S. Marshals Service has conducted a mass seizure of FDA-regulated products that were being held in an Arkansas grocery warehouse under insanitary conditions

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

Fri, 2018-11-09 09:22
FDA authorizes emergency use of first Ebola fingerstick test with portable reader

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program

Thu, 2018-11-08 11:08
The FDA is committed to the expanded access program which provides a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases and life-threatening conditions outside of clinical trials when no comparable or satisfactory approved alternative therapy options are available.

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

Thu, 2018-11-08 08:18
FDA approves new version of OTC Primatene Mist inhaler to treat mild, intermittent asthma for people who have been diagnosed with asthma by their physician

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

Mon, 2018-11-05 10:10
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

FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery

Fri, 2018-11-02 13:52
FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery

FDA and DoD formalize collaboration to advance medical products in support of American military personnel

Fri, 2018-11-02 12:45
FDA and DoD formalize collaboration to advance medical products in support of American military personnel. New Memorandum of Understanding aligns agency efforts to foster the development and use of safe and effective medical products for members of the U.S. military.

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s approval of Dsuvia and the FDA’s future consideration of new opioids

Fri, 2018-11-02 12:29
FDA announces approval of Dsuvia and new steps the agency may be taking to evaluate opioids.

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

Fri, 2018-11-02 08:46
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

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

Thu, 2018-11-01 15:53
Roche Diagnostics issued voluntary recall of certain test strips used with CoaguChek meter devices; patients affected by the recall should seek alternative methods for testing.

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

Thu, 2018-11-01 13:24
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

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