Sunday, April 28, 2024

Sunday, April 28, 2024

Regulation

Regulation

U.S. FOOD AND DRUG ADMINISTRATION: 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

By Press release submission | Apr 16, 2019

Regulation

U.S. FOOD AND DRUG ADMINISTRATION: New opioid analgesic labeling changes to give providers better information for how to properly taper patients who are physically dependent on opioids

By Press release submission | Apr 9, 2019

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U.S. FOOD AND DRUG ADMINISTRATION: FDA takes new steps to increase access to adverse event report data for medical products used in animals

By Press release submission | Apr 8, 2019

Latest News

U.S. FOOD AND DRUG ADMINISTRATION: FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products

Regulation

By Press release submission | Apr 4, 2019

Statement by FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk, while progressing the agency’s commitment to help advance legitimate stem cell product development under existing agency regulations

U.S. FOOD AND DRUG ADMINISTRATION: 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

Regulation

By Press release submission | Apr 3, 2019

In recent years, we’ve seen a growing interest in the development of therapies and other FDA-regulated consumer products derived from cannabis (Cannabis sativa L.) and its components, including cannabidiol (CBD).

U.S. FOOD AND DRUG ADMINISTRATION: Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs

Regulation

By Press release submission | Apr 3, 2019

We’ve long recognized that compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product.

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

Regulation

By Press release submission | Mar 30, 2019

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

Regulation

By Press release submission | Mar 28, 2019

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

Regulation

By Press release submission | Mar 28, 2019

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

Regulation

By Pat Morris | Mar 26, 2019

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

Regulation

By John Breslin | Mar 24, 2019

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

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By Pat Morris | Mar 23, 2019

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

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By Pat Morris | Mar 23, 2019

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

Regulation

By Pat Morris | Mar 22, 2019

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

Regulation

By Press release submission | Mar 19, 2019

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.

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