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FDA Finds Problems with Manufacturing Records at Sun Plant: Report

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FDA inspectors reportedly collect incomplete records during a surprise inspection that began earlier this month at Sun Pharmas Hal...

Pulse Generator Devices into Class 2

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Federal Register Proposed order: FDA proposes to reclassify the external pacemaker pulse generator devices into Class 2.

FDA Withdraws Proposed Rule on Pulse Generator Devices

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Federal Register Proposed rule: FDA withdraws a proposed rule reclassifying the external pacemaker pulse generator devices.

Acura Pharma Files Dispute Resolution Request on Vycavert

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Acura Pharmaceuticals files a formal dispute resolution request for Vycavert, an abuse-deterrent formulation of hydrocodone and ac...

FDA Accepts Tuzistra NDA for Cough/Cold

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FDA accepts for review a Vernalis and Tris Pharma NDA for Tuzistra XR (CCP-01), an extended-release liquid said to be equivalent t...

FDA Panel Narrowly Backs NPS Pharmas Natpara

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FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes 8 to 5 that available data support approval of NPS Pharmaceutical...

DoJ Files Motion Against Bayer and its Dietary Supplement Marketing

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The Department of Justice files a motion seeking to hold Bayer in contempt for violating a 2007 court order prohibiting it from ma...

FDA Approves Cochlears 2.4 GHz Wireless Connectivity

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FDA approves a Cochlear Ltd. PMA to use 2.4 GHz wireless connectivity with its Cochlear Nucleus 6 Sound Processor for use with hea...

Group Seeks Guidance Development Process Reforms

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The Combination Products Coalition asks to meet with FDA to discuss needed reforms to the agencys guidance development process.

CDER Promotes Attorney Sipes in Regulatory Policy Shop

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CDER promotes senior regulatory counsel Grail Sipes to director of the Centers Office of Regulatory Policy.