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FDA Lifts Clinical Hold on Proellex

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FDA reclassifies a full clinical hold on Repros Therapeutics oral Proellex to a partial clinical hold to allow a Phase 2 study eva...

HHS IG is Asked for More Corporate Integrity Guidance

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Companies that have signed a corporate integrity agreement ask the HHS Inspector General for additional guidance on compliance act...

Petition Seeks Medifil Sodium Chloride RLD Designation

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A citizen petition requests that FDA designate Medefils sodium chloride injection, USP, 0.9% in prefilled plastic syringes as a se...

Guidance on Drugs for Acute Bacterial Sinusitis

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Federal Register Notice: FDA releases a guidance, Acute Bacterial Sinusitis: Developing Drugs for Treatment.

FDA Cracks Down on Unapproved B&L, Akorn Drugs

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FDA issues Warning Letters to Bausch & Lomb and Akorn for manufacturing and shipping unapproved pilocarpine hydrochloride ophthalm...

Mutual Petitions FDA to Block Generic Colcrys

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Mutual Pharmaceutical Co. petitions FDA seeking to prevent ANDAs referencing Colcrys (colchicine) that may carve out its indicatio...

Inspection Finds QS Problems at Hospira Costa Rica

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FDA warns Hospira Costa Rica about Quality System Regulation violations in its manufacturing of infusion pumps and intravascular a...

Sanofi, Mass General Partner on Tumor Therapy Development

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Sanofi announces a two-year agreement with Massachusetts General Hospital to advance translational medicine research and to develo...

History of Pharmacy Compounding: Its Values and Risks

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FDA Webview editor Jim Dickinson reviews the frustrating history of compounding pharmacys relations with FDA in light of the curre...

FDA Posts Zimmer Warning Letter on Validation Issue

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FDA releases a Warning Letter to Zimmer over manufacturing and validation issues cited after an inspection at a manufacturing faci...