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Press releases from FDA
Updated: 1 hour 58 min ago

Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples

Tue, 2019-04-23 09:41
Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples

Statement from Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine

Mon, 2019-04-22 11:29
The FDA wants to underscore our continued confidence in the safety and effectiveness of the vaccines that are highly successful at preventing – in some cases, nearly eradicating – preventable diseases. Large well-designed studies have confirmed the safety and effectiveness of the MMR vaccine and have demonstrated that administration of the vaccine is not associated with the development of autism. MMR vaccine has been approved in the United States for nearly 50 years to prevent measles, mumps and rubella (also known as German Measles). As a result of its use, measles and rubella were completely eradicated in the United States, and mumps cases decreased by 99%.

FDA permits marketing of first medical device for treatment of ADHD

Fri, 2019-04-19 17:08
FDA permits marketing of first medical device for treatment of ADHD

FDA approves first generic naloxone nasal spray to treat opioid overdose

Fri, 2019-04-19 10:20
FDA granted approval of the 1st generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose

FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements

Tue, 2019-04-16 11:42
FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements

FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices

Tue, 2019-04-16 10:49
FDA informs companies that the agency is not approving their PMA applications and that they will have to remove their products from the market

Statement from Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, on agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility

Fri, 2019-04-12 14:40
FDA efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility

FDA approves first targeted therapy for metastatic bladder cancer

Fri, 2019-04-12 12:32
The FDA granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy.

Statement from Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on continued efforts to assess duodenoscope contamination risk

Fri, 2019-04-12 09:43
FDA provides updates on post-marketing study that agency ordered three manufacturers of duodenoscopes to conduct to prevent bacterial contamination of devices.

FDA orders important safety labeling changes for Addyi

Thu, 2019-04-11 14:24
FDA has issued a safety labeling change order to Sprout Pharmaceuticals for their drug, Addyi requiring the company to revise important safety information.

FDA issues final rule on safety and effectiveness of consumer hand sanitizers

Thu, 2019-04-11 08:34
FDA issues a final rule designed to help ensure that hand sanitizers available over-the-counter are safe and effective for those who rely on them. The rule establishes that certain active ingredients are not allowed to be used in OTC hand sanitizers, formally known as topical consumer antiseptic rub products, which are intended for use without water, that are marketed under the FDA’s OTC Drug Review.

Declaración del comisionado de la FDA sobre los esfuerzos continuos para impedir que las clínicas de células madre comercialicen productos no aprobados, y que reitera al mismo tiempo el compromiso de la dependencia de ayudar a avanzar en el desarrollo...

Wed, 2019-04-10 16:38
Declaración de la FDA sobre las acciones de aplicación de las normas sobre células madre y las actividades de la dependencia para facilitar el desarrollo de productos legítimos

FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion

Wed, 2019-04-10 10:21
FDA is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI.

USDA, EPA, and FDA Unveil Strategy to Reduce Food Waste

Tue, 2019-04-09 14:37
The agencies announced the release of a federal interagency strategy to address food waste.

FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture

Tue, 2019-04-09 14:23
FDA approves a new treatment for osteoporosis in postmenopausal women at high risk of breaking a bone (fracture).

Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients...

Tue, 2019-04-09 14:07
Agency issued a drug safety communication to make doctors and patients aware of the labeling changes and the need for careful tapering to avoid side effects

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment

Mon, 2019-04-08 14:31
FDA today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. This is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received antiretroviral treatment for HIV.

FDA warns about risks of using home use test strips that are pre-owned or not authorized for sale in U.S., including those for glucose, warfarin

Mon, 2019-04-08 10:25
FDA warns about risks of using home use test strips that are pre-owned or not authorized for sale in U.S., including those for glucose, warfarin

FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications

Thu, 2019-04-04 13:11
FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications

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