Press Announcements
Note: Press announcements from 2004 to 2015 are available through the FDA.gov Archive. Some links in press announcements may no longer be active. For more information, contact FDA’s Office of Media Affairs at 301-796-4540.
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January 2019
- January 17, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D., on unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths
- January 16, 2019 - FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy
- January 15, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D. and Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies
- January 07, 2019 - 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
December 2018
- December 21, 2018 - FDA permits marketing of a diagnostic test to aid in measuring nutrients in breast milk
- December 21, 2018 - FDA approves new treatment for adult patients with rare, life-threatening blood disease
- December 21, 2018 - FDA approves first treatment for rare blood disease
- December 20, 2018 - 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
- December 20, 2018 - 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
- December 20, 2018 - FDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation
- December 20, 2018 - 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
- December 18, 2018 - 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
- December 18, 2018 - 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
- December 17, 2018 - Michigan-based food manufacturer agrees to stop operations after repeated food safety violations
- December 13, 2018 - 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
- December 13, 2018 - 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
- December 12, 2018 - 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
- December 11, 2018 - FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications
- December 11, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework
- December 10, 2018 - 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
- December 10, 2018 - FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs
- December 10, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs
- December 06, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics
- December 06, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products
- December 04, 2018 - FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care
November 2018
- November 30, 2018 - FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus
- November 29, 2018 - FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency’s ongoing Youth Tobacco Prevention Plan
- November 28, 2018 - FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder
- November 28, 2018 - FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation
- November 28, 2018 - FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma
- November 27, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway
- November 27, 2018 - Statement by FDA Commissioner Scott Gottlieb, M.D., on risk of heavy metals, including nickel and lead, found in some kratom products
- November 27, 2018 - FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients
- November 26, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation
- November 26, 2018 - FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor
- November 26, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices
- November 21, 2018 - FDA approves new treatment for patients with acute myeloid leukemia
- November 20, 2018 - FDA warns marketers of products labeled as dietary supplements that contain tianeptine for making unproven claims to treat serious conditions, including opioid use disorder
- November 20, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on FDA’s updates to Medical Device Safety Action Plan to enhance post-market safety
- November 20, 2018 - FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease
- November 19, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim for consuming oils with high levels of oleic acid to reduce coronary heart disease risk
- November 16, 2018 - FDA approves new drug to treat travelers’ diarrhea
- November 16, 2018 - Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the regulation of cell-cultured food products from cell lines of livestock and poultry
- November 16, 2018 - 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
- November 16, 2018 - FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot
- November 16, 2018 - 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
- November 15, 2018 - Results from 2018 National Youth Tobacco Survey show dramatic increase in e-cigarette use among youth over past year
- November 15, 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
- November 14, 2018 - 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
- November 13, 2018 - 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