FDA Related News

Human Drugs

$250 Million in Counterfeit HIV Drugs Sold: Gilead

Gilead says it believes it has stopped the distribution of counterfeit HIV drugs from reaching patients.

Medical Devices

Getinge Recalls Vaporizer Sevoflurane Maquet Filling

Getinge recalls its Vaporizer Sevoflurane Maquet filling due to the potential chemical breakdown of Sevoflurane, a general surgical anesthetic.

Human Drugs

Multiple Violations at Professional Disposables

FDA warns Orangeburg, NY-based Professional Disposables International about CGMP and FAR violations in its manufacturing of a drug product.

Federal Register

FDA Corrects Notice on ANDA Withdrawal

Federal Register notice: FDA corrects a 10/22/2021 notice that announced the withdrawal of 216 ANDAs.

Medical Devices

Device Plan on Womens Health Priorities

CDRH releases its Health of Women Program Strategic Plan that intends to boost related regulatory science, and identify and address current and emergi...

Medical Devices

DTM Stimulation Meaningful Results: Medtronic

Medtronic says its DTM SCS endurance therapy showed meaningful pain relief results in a clinical trial.

CGMP and QS Violations in Sunstar Inspection

FDA warns Schaumburg, IL-based Sunstar Americas about drug CGMP and medical device QS violations at its manufacturing facility.

Human Drugs

Complex Innovative Trial Case Studies

FDA releases three case study summaries from the complex innovative trial design pilot program.

Human Drugs

Catalent Belgium FDA-483

FDA issues the latest FDA-483 from an inspection at the troubled Catalent fill and finish contract manufacturing facility in Brussels, Belgium.

Human Drugs

CGMP Violations at South Koreas Cosmo Bio

FDA warns South Koreas Cosmo Bio about CGMP violations in its production of a misbranded and unapproved over-the-counter acne drug.