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FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes American Fertility Medical Center, HomeChoice Partners and Gaia Arise Farms Apothecary.

Federal Register

Guide on Vet Drug Stability Testing

Federal Register notice: FDA makes available a final guidance entitled Stability Testing of New Veterinary Drug Substances and Medicinal Products in C...

Human Drugs

Stop Selling Unapproved Covid-19 Treatment: FDA

FDA warns Gaia Arise Farm Pharmacy about its sale of unapproved and unauthorized products intended to treat Covid-19.

Federal Register

Info Request on Vaping Products Extended

Federal Register notice: FDA extends the comment period until 6/19 for a request for information related to vaping products associated with lung injur...

Human Drugs

NCLA Warns of FDA Genetic Variants Overreach

The New Civil Liberties Alliance calls on FDA to rescind a decision that it says prevents the dissemination of information on the impact of genetic va...

Human Drugs

HomeChoice Sterile Drug Product Deficiencies Cited

FDA warns HomeChoice Partners about deficiencies in its production of sterile drugs.

Changes Suggested for Bridging Guidance

Two stakeholders recommend changes to an FDA draft guidance on bridging for combination products.

Medical Devices

Intact Vascular Endovascular System Okd

FDA approves Intact Vasculars Tack Endovascular System (4F), a minimal metal implant for precision dissection repair in certain critical limb ischemia...

Human Drugs

FDA Clears 4 India Drug Plants

FDA clears four Indian drug manufacturing facilities within 10 days to ease supply chain disruptions caused by the pandemic.

Human Drugs

Fennec Pharma NDA Priority Review for Pedmark

FDA accepts for priority review a Fennec Pharmaceuticals NDA for Pedmark (sodium thiosulfate), indicated for preventing ototoxicity induced by cisplat...