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Quality Violations Found at Atrium Medical Corp

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FDAs New England District Office warns Atrium Medical Corp. about Quality System violations in its manufacturing of several medica...

FDA Continuing to Look at OTC with Special Conditions

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CDER Office of Medical Policy deputy director Rikin Mehta says FDA is moving forward with its exploration of whether some drugs co...

CDER Planning Patient Medication Information Sheets to Replace MedGuides

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CDER plans to replace Medication Guides, patient-package inserts, and other consumer medication information handed out at pharmaci...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Atrium Medical, BioHealth Solutions, Steven W. Boyce, Global Source Management &...

CDRH Workshop Transcript for Post Approval Studies

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CDRH posts a transcript of a workshop held 8/30 on Post Approval Studies: Design, Methodology, and Role in Evidence Appraisal Thro...

Titan Pharma Files NDA for Drug Implant

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Titan Pharmaceuticals files a 505(b)(2) NDA for Probuphine (buprenorphine hydrochloride), indicated for treating opioid dependence...

Warner Chilcott Petitions for Tighter Generic Asacol Bioequivalence

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Warner Chilcott petitions FDA asking it to tighten bioequivalence criteria for ANDA sponsors seeking approval for generic copies o...

Class 1 Recall of Hospira Touchscreen Drug Infusion Pumps

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FDA classifies as Class 1 a recall involving Hospiras Symbiq One- and Two-Channel Infuser touchscreen drug pumps.

Rep. Markey Report Supports More FDA Compounding Oversight

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A new report from Rep. Edward Markey (D-MA) calls for more FDA oversight authority over pharmacy compounding.

FDA Priority Review for Stivarga

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FDA grants priority review to Bayer HealthCare for its NDA for Stivarga (regorafenib) tablets, indicated to treat patients with me...