Statement from Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health on quality issues with certain Cardinal Health surgical gowns and packs

Romaine outbreaks declared over, investigation advances, root cause analysis continues

Home Style Foods, Inc., a Michigan-based food manufacturer, has agreed to discontinue selling food products until the company complies with federal regulations and other requirements.

The U.S. Food and Drug Administration today approved two applications for first generics of Eliquis (apixaban) tablets.

Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review

GAO issued the report “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs,” which contains a single recommendation for the FDA -- that the agency publicly announce its plans to issue or revise guidance for these drug products. The FDA agrees and is actively working to accomplish this goal.

Enabling patients and providers to have efficient access to new and innovative medical products that meet the FDA’s gold standard for safety and effectiveness is a core part of our mission. We’re advancing these goals as part of the Medical Innovation Access Plan that I announced earlier this year. While we’ve unveiled parts of that plan already, we’ll be releasing its full detail shortly. As one part of that effort, we’re announcing some additional steps we’re taking right now to promote beneficial medical device innovation.

The FDA is releasing the Medical Device Safety Action Plan that outlines our vision for how FDA can continue to enhance our programs and processes to assure the safety of medical devices

FDA approved Ayvakit (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation

The Trump Administration is taking steps to lower prescription drug prices by proposing a rule that could allow for the importation of certain drugs from Canada and issuing draft guidance explaining how manufacturers could import drugs, biological products originally intended for sale abroad.

FDA, USDA and EPA launch Unified Website for Biotechnology Regulation to streamline information about agriculture biotechnology products.

FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint

FDA approves Ubrelvy (ubrogepant) tablets for the acute treatment of migraine with or without aura in adults.

FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting

The U.S. Food and Drug Administration today expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years of age and older with diabetes.

FDA announced today the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older.

The FDA and the Drug Enforcement Administration have seized 44 websites advertising the sale of illicit THC vaping cartridges.

Today, the agency is announcing the Compounding Quality Center of Excellence – an initiative designed to improve the overall quality of compounded medicines.

National Academies of Sciences, Engineering, and Medicine (NASEM) was tasked with providing a framework to evaluate current and future opioid prescribing to support a clinical practice guideline and to identify gaps in the evidence.

FDA granted accelerated approval to Padcev, a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells – in this case, the cell adhesion molecule Nectin-4 which is highly expressed in urothelial cancers