FDA Press Releases

1,264 Press Releases

Published on January 22, 2019 - 16:08 GMT

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological ...

In 2018, the FDA’s Center for Devices and Radiological Health achieved several new milestones, including a record-setting year for approvals of novel medical devices. We also focused on advancing several meaningful initiatives and policy proposals aimed …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on January 17, 2019 - 16:40 GMT

Statement from FDA Commissioner Scott Gottlieb, M.D., on unprecedented new efforts to support development of over-the-counter ...

With the number of overdose deaths involving prescription and illicit opioids more than doubling over the last seven years to nearly 48,000 in 2017, it’s critical that we continue to address this tragedy from all fronts. This includes new ways to increase …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on January 16, 2019 - 18:30 GMT

FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy

The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on January 16, 2019 - 16:59 GMT

Statement from FDA Commissioner Scott Gottlieb, M.D. and Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation ...

The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced by a large upswing in the number of investigational new drug (IND) applications. Based on this activity, we anticipate that the number of product …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on January 7, 2019 - 18:04 GMT

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new actions under the Pre-Cert Pilot Program to promote a ...

Digital technologies create new opportunities to transform health care and empower patients to make better informed decisions about their health. Digital tools are rapidly evolving, and to keep pace with this promising innovation, the FDA must modernize …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on December 21, 2018 - 19:39 GMT

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

Today, the U.S. Food and Drug Administration permitted marketing of the Miris Human Milk Analyzer, a new diagnostic test to aid healthcare professionals in measuring nutrients in breast milk, including the concentration of fat, carbohydrate, protein, …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on December 21, 2018 - 18:57 GMT

FDA approves first treatment for rare blood disease

The U.S. Food and Drug Administration today 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. “Prior to today’s approval …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on December 21, 2018 - 16:12 GMT

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

The U.S. Food and Drug Administration today approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease. “The approval of Ultomiris will change …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on December 20, 2018 - 22:08 GMT

Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of ...

Today, the Agriculture Improvement Act of 2018 was signed into law. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on December 20, 2018 - 19:12 GMT

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure ...

When new safety concerns arise for particular devices, we’re committed to taking action to develop post-market information that can help patients and providers make more informed decisions and also support regulatory actions that reduce any potential …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on December 20, 2018 - 17:05 GMT

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

Today, the U.S. Food and Drug Administration alerted parents, caregivers and health care providers to the safety risks that jewelry used for relieving teething pain pose for children. The agency warned that they should not be used to relieve teething pain …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on December 20, 2018 - 16:25 GMT

FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem ...

The U.S. Food and Drug Administration has warned Genetech, Inc. of San Diego, California and its president, Edwin N. Pinos for marketing stem cell products without FDA approval and for significant deviations from current good tissue practice (CGTP) and …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on December 18, 2018 - 15:46 GMT

Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological ...

Spurring innovation of medical products so that patients can have access to safe, effective treatments that improve or save lives is a fundamental part of our mission. We’ve taken several steps to enhance how we deliver on this mission through the goals …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on December 18, 2018 - 15:05 GMT

Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s 2017 report on declining sales/distribution of antimicrobial ...

Every year, at least two million Americans are sickened by serious infections caused by antimicrobial-resistant (AMR) pathogens, such as MRSA. And, at least 23,000 people die as a direct result of these infections. AMR is the ability of a microorganism ( …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on December 17, 2018 - 21:43 GMT

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

A federal court ordered a Michigan-based food manufacturer to discontinue selling food products until the company complies with federal regulations and other requirements. This action follows several inspections conducted by the U.S. Food and Drug …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on December 13, 2018 - 22:04 GMT

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated ...

On Nov. 20, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention warned the American public of a multi-state outbreak of E. coli O157:H7 linked to romaine lettuce and advised against eating any romaine lettuce on the …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on December 13, 2018 - 14:35 GMT

Statement from FDA Commissioner Scott Gottlieb, M.D. and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, ...

Protecting patient safety is at the core of the FDA’s mission. All FDA-approved drugs have benefits and risks which must be weighed and balanced by health care providers and patients when making decisions about medical therapy. For our part, the FDA is …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on December 12, 2018 - 15:47 GMT

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to improve drug quality through vigilant oversight ...

Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission. Overseeing the quality and safety of pharmaceutical manufacturing is key to these efforts. With the emergence of new markets, supply chains are more …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on December 11, 2018 - 23:09 GMT

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

The U.S. Food and Drug Administration today released a warning letter issued to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP), in Linhai, Taizhou Zhejiang China, the manufacturer of the active pharmaceutical ingredient (API) found in valsartan that is the …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on December 11, 2018 - 15:00 GMT

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

Our public health obligations touch on many aspects of how medical products are developed and used by patients and providers. The bedrock of our mission is our consumer protection role – our obligation to protect patient safety. Part of our mission also …

Distribution channels: Healthcare & Pharmaceuticals Industry

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