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Draeger Recalls Ventilator Over Battery Issues

[ Price : $8.95]

Draeger Medical recalls its Oxylog 3000 Plus Emergency and Transport Ventilator after receiving reports that the device stopped ve...

Cell, Gene Manufacturing Changes, Comparability

[ Price : $8.95]

FDA publishes a draft guidance on managing manufacturing changes for human cellular and gene therapy products.

Opill Approved as 1st OTC Oral Contraceptive

[ Price : $8.95]

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

Dr. Reddys Rituxan Biosimilar BLA Accepted

[ Price : $8.95]

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

FDA Wants More PSA Applicants

[ Price : $8.95]

CDER Office of Generic Drugs associate director of stakeholder and global engagement Sarah Ibrahim uses an agency podcast to urge ...

CGMP, Other Issues at NeilMed Pharmaceuticals

[ Price : $8.95]

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

Disclose Drug, Supplement Animal Ingredients: Petition

[ Price : $8.95]

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

Boston Scientific Brain Stimulation Software OKd

[ Price : $8.95]

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

FDA Warns 2 Firms on Human Cells/Tissues

[ Price : $8.95]

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

Most Common 2022 BIMO Violations

[ Price : $8.95]

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