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Drug Shortage Tide is Ebbing: Report

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An NBC News report says the pace of new drug shortage reports seems to be slowing.

Genentech Survives Preemption Argument in Raptiva Injury Case

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An appeals court affirms a lower court decision that claims brought in a consolidated products liability suit involving Genentechs...

FDA Hits Lilly on Web Page Colored Images

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An FDA untitled letter to Eli Lilly cites the companys use of a promotional Web page for brain imaging drug Amyvid because it incl...

Janssen Resubmits Xarelto sNDAs to Address FDA Questions

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Janssen Research & Development refiles two supplemental NDAs for Xarelto following information requested by FDA in a 6/21 complete...

CDRH Outlines Actions to Strengthen Postmarket Surveillance

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A just-posted CDRH white paper outlines four specific actions the Center plans to focus on to strengthen its medical device postma...

AstraZeneca Scraps Obesity Drug Candidate

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AstraZeneca stops developing a weight-loss compound designated AZD2820 due to safety concerns.

Generic Drugs and Drug Quality Elevated in CDER Reorganization

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A proposed reorganization by CDER director Janet Woodcock elevates the Office of Generic Drugs to a super office and plans a new o...

Industry Praises Guidance on Transferring Clinical Oversight

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Five drug companies express general support for an FDA draft guidance on transferring clinical oversight responsibility from one I...

FDA Warns Concussion Supplement Marketers

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FDA sends Warning Letters to PruTect Rx (Highlands Ranch, CO) and Trinity Sports Group (Plano, TX) for promoting dietary supplemen...

Celgene PLans NDA for Psoriatic Arthritis

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Celgene International plans to file an NDA early in 2013 for apremilast, indicated for treating patients with psoriatic arthritis.