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Guidance on Rare Pediatric Disease Vouchers

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Federal Register Notice: FDA releases a draft guidance: Rare Pediatric Disease Priority Review Vouchers.

FDA Withdraws 14 NDAs

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Federal Register Notice: FDA withdraws approval of 14 NDAs from multiple application holders due to a failure to file annual repor...

FDA Corrects Notice on Withdrawn Drug Products

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Federal Register Proposed rule: FDA corrects the Regulatory Information Number in a 7/2 notice on additions and modifications to a...

FDA Clears K2M Capri Corpectomy Cage System

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FDA clears a K2M 510(k) for its Capri Corpectomy Cage System, an expandable vertebral body replacement device for use following a ...

Frivolous Petitions Continue to be Submitted: FDA

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A new report from FDA to Congress says the agency is concerned that too many petitions continue to be submitted as a strategy to d...

FDA Evaluating Higher Death Rate with Dual Antiplatelet Therapy

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FDA says it is evaluating preliminary data from a clinical trial showing an increased overall risk of death for patients on dual a...

Genzyme Gains Approval for Lemtrada for MS

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FDA approves a Genzyme NDA for Lemtrada (alemtuzumab) for treating patients with relapsing forms of multiple sclerosis.

Solgar Recalls Dietary Supplement Due to Fungus

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Solgar, Inc. recalls its ABC Dophilus Powder after testing by the Centers for Disease Control revealed the presence of Rhizopus or...

FDA Seeking to Double Inspectional Presence In China

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FDA says an ongoing hold on China-issued visas is expected to be lifted in the coming weeks which will double its inspectional pre...

84% Say CDRH Delivering Good Customer Service

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An ongoing CDRH customer survey finds that 84% of respondents are satisfied with the Centers customer service.