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Outsourcing Facility Registration Guidance

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FDA issues a guidance to help entities determine whether to register as a Section 503B outsourcing facility.

FDA Accepts La Jolla IND for Iron Overload Therapy

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FDA accepts a La Jolla Pharmaceutical Co. IND for its novel formulation of hepcidin, indicated for treating iron overload.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Alphatec Spine, R Thomas Marketing, and Royal Case Co.

Comments, Questions on Male-Mediated Risk Guidance

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Five drug companies raise questions about and suggest changes to an FDA draft guidance on assessment of male-mediated developmenta...

U.S. Charges Canada Pharmacy Over Counterfeit Drugs

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U.S. government prosecutors charge an online Canadian pharmacy with selling $78-million worth of unapproved and counterfeit drugs ...

Supernus Petitions FDA for Tighter Oxtellar Bioequivalence

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Supernus Pharmaceuticals petitions FDA to require tighter bioequivalence parameters for ANDA applicants seeking to market generic ...

FDA Approves Taro NDA for Keveyis

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FDA approves a Taro Pharmaceutical Industries NDA for Keveyis (dichlorphenamide) 50 mg tablets for treating primary hyperkalemic a...

Panels Will Discuss Purdues Oxycodone Immediate-Release Tablets

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Federal Register Notice: Two FDA advisory committees will meet 9/10 to discuss Purdue Pharmas oxycodone immediate-release tablets....

Panels to Discuss Collegium Pharma Opioid

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Federal Register Notice: Two FDA panels will discuss a Collegium Pharmaceuticals NDA for oxycodone extended-release capsules for o...

Alcon Recalls ReSTOR Intraocular Lenses

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Alcon Research begins a Class 1 recall of ReSTOR and ReSTOR Toric intraocular lens due to patient reports of asceptic endophthalmi...