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Press releases from FDA
Updated: 1 hour 53 min ago

Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls

Fri, 2017-11-17 08:03
Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts by the agency to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls

FDA expands approval of Sutent to reduce the risk of kidney cancer returning

Thu, 2017-11-16 14:35
FDA approves first adjuvant treatment for adult patients who are at a high risk of kidney cancer returning after a kidney has been removed.

FDA approves new treatment to prevent bleeding in certain patients with hemophilia A

Thu, 2017-11-16 10:26
FDA approves new treatment to prevent or reduce frequency of bleeding episodes in patients with hemophilia A who have Factor VIII inhibitors.

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

Thu, 2017-11-16 08:23
Commissioner statement on FDA’s comprehensive regenerative medicine policy framework to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy

FDA announces comprehensive regenerative medicine policy framework

Thu, 2017-11-16 08:22
FDA announces comprehensive regenerative medicine policy framework to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy.

FDA unveils a streamlined path for the authorization of tumor profiling tests alongside its latest product action

Wed, 2017-11-15 12:16
Newly authorized test detects genetic cancer mutations in 468 unique genes

FDA approves treatment for rare genetic enzyme disorder

Wed, 2017-11-15 11:10
FDA approves treatment for rare genetic enzyme disorder

FDA grants marketing authorization of the first device for use in helping to reduce the symptoms of opioid withdrawal

Wed, 2017-11-15 10:17
FDA permits marketing of the first device for use in helping to reduce the symptoms of opioid withdrawal

FDA warns about illegal use of injectable silicone for body contouring and associated health risks

Tue, 2017-11-14 08:59
FDA issues safety communication about illegal use of injectable silicone for body contouring and associated health risks

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom

Tue, 2017-11-14 07:58
A botanical substance known as kratom has raised significant concerns given its increasing prevalence and potential safety risks. The FDA has issued a public health advisory related to mounting concerns regarding risks associated with the use of kratom.

FDA approves pill with sensor that digitally tracks if patients have ingested their medication

Mon, 2017-11-13 18:00
The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

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

Wed, 2017-11-08 10:00
To further streamline the submission and review process for shared system REMS (for any REMS that includes more than one medication), today the FDA is releasing a draft guidance for industry, Use of a Drug Master File for Shared System REMS Submissions, that describes how applicants can submit collective sets of files to the FDA that represent all participating firms.

FDA clears common blood cell count test that offers faster results for patients and providers

Mon, 2017-11-06 13:23
The U.S. Food and Drug Administration today cleared a complete blood cell count (CBC) test that, based on its categorization, can be run in more health care settings, including physicians’ offices, clinics or other types of health care facilities, by a wider range of personnel (e.g. support staff). This broadened test access will allow for faster availability of results.

FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer

Mon, 2017-11-06 10:31
FDA expands approval of Zelboraf (vemurafenib) to include treatment of certain adult patients with Erdheim-Chester Disease, a rare blood cancer. This is the first FDA-approved treatment for ECD.

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

Mon, 2017-11-06 08:25
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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