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FDA Accepts Applications for Latuda Expanded Indications

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FDA accepts for review two applications from Sunovion for expanded indications for its schizophrenia drug Latuda.

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...

FDA Sends Info on Xenotransplantation to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the PHS guideline on infectious disease issues in xen...

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...

Radiological Panel Backs Expanded Breast Screening Use

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FDAs Radiological Devices Panel votes 9 to 1 to recommend the approval of a Hologic PMA supplement to expand the use for its Selen...

Class 1 Recall for Stryker Neptune Waste System

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FDA classifies as a Class 1 recall a Stryker warning to healthcare providers about potential serious injuries to surgical patients...