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News & Events

Statement from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic

Wed, 2019-05-15 21:27
FDA issues first warning letter under Drug Supply Chain Security Act to McKesson Corp. for violations highlighted by a concerning tampering incident.

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

Wed, 2019-05-15 21:27
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 FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility

Wed, 2019-05-15 21:27
The FDA is aware that the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop a contract sterilizer, Sterigenics, from sterilizing medical products and other products with gas called ethylene oxide at their Willowbrook, Illinois facility.

Statement from Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on policies designed to capture more data to better understand effects of prescription drugs...

Wed, 2019-05-15 21:27
The FDA is issuing two draft guidances, which, when finalized, will provide new and updated information for companies designed to increase the availability of high-quality safety information in drugs used during pregnancy or lactation.

FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

Wed, 2019-05-15 21:27
FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis

Wed, 2019-05-15 21:27
FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis

FDA takes new enforcement actions as part of the agency’s ongoing effort to combat the illegal online sales of opioids

Wed, 2019-05-15 21:27
Agency issued two warning letters to operators of websites that illegally market potentially dangerous, unapproved and misbranded opioid medications.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products

Wed, 2019-05-15 21:27
FDA is announcing a number of important new steps and actions to advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities.

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

Wed, 2019-05-15 21:27
FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications

Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of...

Thu, 2019-05-02 22:39
Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of breast implants

First FDA-approved vaccine for the prevention of dengue disease in endemic regions

Thu, 2019-05-02 22:39
FDA approves first vaccine for prevention of dengue disease in people ages 9-16 who have laboratory-confirmed previous dengue infection and live in endemic areas, such as the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.

La FDA exige advertencias más estrictas sobre incidentes poco comunes, pero graves, relacionados con ciertas medicinas recetadas para el insomnio

Thu, 2019-05-02 22:39
La FDA exige advertencias más estrictas sobre incidentes poco comunes, pero graves, relacionados con ciertas medicinas recetadas para el insomnio: eszopiclona, zaleplón y zolpidem.

FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway

Tue, 2019-04-30 19:19
FDA has authorized the marketing of new tobacco products manufactured by Phillip Morris Products S.A. for the IQOS “Tobacco Heating System.”

FDA approves first treatment for all genotypes of hepatitis C in pediatric patients

Tue, 2019-04-30 19:19
FDA approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17.

FDA requires stronger warnings about rare but serious incidents related to certain prescription insomnia medicines

Tue, 2019-04-30 19:19
FDA requires stronger warnings about rare but serious incidents related to certain prescription insomnia medicines - eszopiclone, zaleplon and zolpidem

FDA statement on approval of OTC Primatene Mist to treat mild asthma

Tue, 2019-04-30 19:19
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

FDA statement on FDA’s modern approach to advanced pharmaceutical manufacturing

Tue, 2019-04-30 19:19
FDA issues information to industry on advanced pharmaceutical manufacturing

FDA Statement on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root causes of the safety issues

Tue, 2019-04-30 19:19
FDA describes the ongoing investigation into the ARB class impurities and agency’s steps to address the root causes of the safety issues

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