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Are FDA Reviewers Really Protecting Confidential Information?

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A recent qui tam lawsuit by FDA reviewers and an insider trading case prompt a prominent lawyer to raise questions about FDAs abil...

FDA Approves Mallinckrodt Supplement for Exalgo

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FDA approves a Mallinckrodt supplemental NDA for a 32 mg tablet strength of Exalgo (hydromorphone HCI) extended-release tablets fo...

FDA Places Hold on Second Idenix Compound

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FDA places a clinical hold on Idenix Pharmaceuticals investigational nucleotide polymerase inhibitor IDX19368 that is being develo...

Depuy Recalls Unused Custom Implants Due to FDA Concerns

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DePuy Orthopedics recalls all unused custom implants as part of its efforts to remediate FDA GMP and quality system issues raised ...

FDA Not Swayed by Humira Data for Proposed Colitis Indication

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FDA reviewers say they are considering whether an additional clinical study is needed before approving an Abbott supplemental BLA ...

FDA OKs Medtronic Arctic Advance Cardiac Cryoballoon

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FDA approves a Medtronic PMA for its Arctic Front Advance Cardiac Cryoballoon for treating paroxysmal atrial fibrillation.

Lilly Reports Disappointing Data in Alzheimers Trials

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Eli Lilly says the cognitive and functional primary endpoints were not met in two Phase 3studies evaluating solanezumab in patient...

FDA DTC Study Leads to Relaxed Claims Data?

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A new FDA-planned research study could lead to a more relaxed approach for using the components of drug efficacy composite scores ...

FDA Denies Endo Petition and Approves Watsons Generic Lidoderm

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Denying a citizen petition seeking tighter bioequivalence standards, FDA approves a Watson Pharmaceuticals ANDA for a generic copy...

Generic Drug User Fee Guidance Coming

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FDA publishes a draft guidance on self-identification for generic drug facilities as part of its implementation of the Generic Dru...