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Court Grants Hearing in Lannett's Unapproved Drug Case

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Lannett and Cody Labs persuade a federal court to grant a motion for reconsideration, allowing them to argue jurisdictional issues...

FDA Panel Nixes Jazz Drug for Fibromyalgia

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An FDA advisory committee recommends that the agency not approve Jazz Pharmaceuticals' Rekinla (sodium oxybate) for treating fibro...

Public Workshop on Pediatric Neuroprostheses

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Federal Register Notice: FDA plans a public workshop 9/13 to seek input to aid in developing more efficient strategies in evaluati...

FDA Extends Review of sNDA for Acetadote

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FDA extends by three months its review of a Cumberland Pharmaceuticals supplemental NDA for using Acetadote (acetylcysteine) injec...

FDA Clears BSD Medical Microwave Ablation System

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FDA clears a BSD Medical Corp. 510 (k) for its MicroThermX Microwave Ablation System (MTX-180) for soft tissue ablation.

FDA Orphan Status for Muscular Dystrophy Therapy

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FDA grants Acceleron Pharma an orphan designation for ACE-031 for treating Duchenne Muscular Dystrophy.

Dr. Reddys Wants Expedited ANDA Review Broadened

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Dr. Reddys asks FDA to add a new scenario to its policy and procedures for expedited review of some ANDAs.

Comments Reopened on Laboratory Developed Tests

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Federal Register Notice: FDA reopens until 9/15 the comment period on FDAs oversight of laboratory developed tests.

GSK Avandia Letter Criticized

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FDAer David Graham and some advisory committee members say a GlaxoSmithKline summary of the advisory committee discussion of Avand...

Despite Misgivings, Advisors Back Cymbalta for Pain

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Members of FDAs Anesthetic and Life Support Drugs Advisory Committee recommend that Lillys Cymbalta be approved for a new indicati...