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Getinge Recalls Vaporizer Sevoflurane Maquet Filling

[ Price : $8.95]

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

Multiple Violations at Professional Disposables

[ Price : $8.95]

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

FDA Corrects Notice on ANDA Withdrawal

[ Price : $8.95]

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

Device Plan on Womens Health Priorities

[ Price : $8.95]

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

DTM Stimulation Meaningful Results: Medtronic

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

CGMP and QS Violations in Sunstar Inspection

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

Complex Innovative Trial Case Studies

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

Catalent Belgium FDA-483

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

CGMP Violations at South Koreas Cosmo Bio

[ Price : $8.95]

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

FDA Rejects Levo Therapeutics Carbetocin NDA

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FDA issues Levo Therapeutics a complete response letter on its NDA for LV-101 (intranasal carbetocin) as a treatment for hyperphag...