FDA Related News

Biologics

Cell, Gene Manufacturing Changes, Comparability

FDA publishes a draft guidance on managing manufacturing changes for human cellular and gene therapy products.

Human Drugs

Opill Approved as 1st OTC Oral Contraceptive

FDA approves a Laboratoire HRA Pharma (recently acquired by Perrigo) NDA to move its contraceptive Opill (norgestrel) tablet from prescription to over...

Biologics

Dr. Reddys Rituxan Biosimilar BLA Accepted

FDA accepts for review a Dr. Reddys Laboratories BLA for its proposed biosimilar rituximab (Genentechs Rituxan) candidate.

Human Drugs

CGMP, Other Issues at NeilMed Pharmaceuticals

FDA warns Santa Rosa, CA-based NeilMed Pharmaceuticals about CGMP and other issues in its production of finished drugs.

Human Drugs

Disclose Drug, Supplement Animal Ingredients: Petition

VeganMed asks FDA to require drug and dietary supplement manufacturers to disclose in product labeling any animal-derived ingredients in their product...

Medical Devices

Boston Scientific Brain Stimulation Software OKd

FDA approves Boston Scientifics Vercis Neural Navigator 5 Software, which is used as part of the Vercise Genus Deep Brain Stimulation System for treat...

Biologics

FDA Warns 2 Firms on Human Cells/Tissues

FDA warns New Hope Center for Reproductive Medicine and Regenerative Labs about violations involving human cells, tissue, and cellular and tissue-base...

Most Common 2022 BIMO Violations

Three Goodwin attorneys analyze the results of BIMO inspections in 2022 and the beginning of 2023, listing most common violations.

Federal Register

Consumer Groups Sought for Advisory Panels

Federal Register notice: FDA asks that consumer organizations notify the agency if they are interested in participating in selecting voting and nonvot...

Federal Register

Guide on Metabolism Inborn Errors

Federal Register notice: FDA makes available a revised draft guidance entitled Inborn Errors of Metabolism That Use Dietary Management: Considerations...