Tuesday, February 25, 2020

Tuesday, February 25, 2020

Latest News

U.S. FOOD AND DRUG ADMINISTRATION: Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward

Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward

U.S. FOOD AND DRUG ADMINISTRATION: Actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule

Statement from FDA Commissioner Scott Gottlieb, M.D., on actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule

U.S. FOOD AND DRUG ADMINISTRATION: New steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products

Seminar scheduled for learning how to handle FDA recalls

No company wants its product recalled by the U.S. Food and Drug Administration, but it can happen despite the most careful product planning.

Feedback flowing in to FDA following draft policy document publication

Feedback is continuing to flow in the FDA following the publication of a draft policy document on the future of combination products.

Administration proposes Medicare patients get coverage for innovative devices

The current administration’s proposed budget for 2020 includes allowing Medicare patients to benefit from more and longer access to “breakthrough” medical devices, and the industry could not be happier.

FDA regulations easier for devices than drugs

The U.S. Food and Drug Administration is the agency that ultimately decides upon the safety of medical applications, both pharmaceuticals and devices, and approves their use by providers to the public.

21st Century Cures Act: Interoperability, information blocking and the ONC Health IT Certification Program

While today's technology offers us a world of information that previous generations never even dreamed of being so accessible, important medical and health records remain time-consuming and difficult to obtain.

U.S. FOOD AND DRUG ADMINISTRATION: FDA takes action against marketer of unapproved products claiming to treat addiction, chronic pain and other serious conditions

The U.S. Food and Drug Administration today posted a warning letter to Nutra Pharma Corp. for illegally marketing unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain, including pain associated with cancer, diabetes, shingles, fibromyalgia and other serious conditions.

FDA Reporter