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Press releases from FDA
Updated: 9 min 4 sec ago

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

Mon, 2019-01-07 11:27
FDA issues three documents that launch next phase of Pre-Cert Pilot Program to test new approaches for the review of digital health device applications.

FDA permits marketing of a diagnostic test to aid in measuring nutrients in breast milk

Fri, 2018-12-21 13:20
The FDA authorized use of a new test that measures nutrients in breast milk providing healthcare professionals with tool to aid in the nutritional management of newborns.

FDA approves new treatment for adult patients with rare, life-threatening blood disease

Fri, 2018-12-21 09:37
The FDA approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease.

FDA approves first treatment for rare blood disease

Fri, 2018-12-21 09:29
The FDA approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older.

Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds

Thu, 2018-12-20 15:35
Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales

Thu, 2018-12-20 12:40
The FDA provides update on Essure postmarket review study as company prepares to halt sales of the device on December 31.

FDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation

Thu, 2018-12-20 10:50
FDA alerted parents, caregivers and health care providers to the safety risks that jewelry used for relieving teething pain pose for children.

FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice

Thu, 2018-12-20 09:03
FDA sends warning letter to Genetech, Inc. and letters to other companies to reiterate the FDA’s compliance and enforcement policy regarding stem cells.

Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to promote innovations in medical devices that help advance patient safety

Tue, 2018-12-18 09:23
FDA announces steps being taken on two medical device programs: finalizing guidance on the Breakthrough Device Program and announcing plans for a new Safer Technologies Program (STeP).

Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s 2017 report on declining sales/distribution of antimicrobial drugs for food animals, a reflection of improved antimicrobial stewardship

Tue, 2018-12-18 08:42
FDA’s 2017 report of sales/distribution data for antimicrobial drugs for food animals showed a continued decline in sales, a reflection of improved antimicrobial stewardship

Michigan-based food manufacturer agrees to stop operations after repeated food safety violations

Mon, 2018-12-17 15:13
Saranac Brand Foods, Inc. specialized in a variety of 35 different ready-to-eat foods, including prepared salads, dips, and sauces.

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce <i>E. coli</i> O157:H7 outbreak investigation

Thu, 2018-12-13 14:56
Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce E. coli O157:H7 outbreak investigation

Statement from FDA Commissioner Scott Gottlieb, M.D. and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on efforts to modernize generic drug labels while maintaining the efficiency of generic development

Thu, 2018-12-13 08:22
FDA announces withdrawal of the proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to improve drug quality through vigilant oversight of data integrity and good manufacturing practice

Wed, 2018-12-12 09:32
FDA releases guidance with recommendations for drug manufacturers regarding good manufacturing practices and data integrity

FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

Tue, 2018-12-11 16:55
FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework

Tue, 2018-12-11 08:55
FDA announces new actions advancing the agency’s biosimilars policy framework

Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data

Mon, 2018-12-10 15:27
FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices.

FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

Mon, 2018-12-10 14:23
FDA clears a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs

Mon, 2018-12-10 09:26
FDA releases guidance with recommendations for protecting patients from the risk of contaminated or substandard compounded products produced by outsourcing facilities.

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