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FDAers Defend Flibanserin Approval

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FDA staffers describe the process the agency followed in first rejecting and then approving Sprouts flibanserin for treating femal...

CDRH Compliance Shifting the Way it Monitors Industry

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CDRH Office of Compliance (OC) acting director Sean Boyd says OC has several initiatives under way to shift the way it monitors or...

New Ionic Liquid Regs Needed: Chemists

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Four chemists write online for Nature that FDA should develop a new regulatory framework to cover ionic liquid drugs.

FDA Withdraws Approval of NADAs/ANADAs

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Federal Register Notice: FDA withdraws approval of two NADAs/ANADAs that are no longer marketed.

Medtronic PMA Approved to Allow MRIs with Neurostimulators

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FDA approves a Medtronic PMA to allow full-body magnetic resonance imaging (MRI) procedures for patients using Activa Deep Brain S...

Pharmalucence Seeks Tougher Stance on Compounders

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Sun Pharmas Pharmalucence urges FDA to take corrective actions to ensure that compounding pharmacies and outsourcing facilities th...

Physicians Challenge FDA Risk Assessment on Morcellators

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A group of 49 physicians from the Leiomyoma Morcellation Review Group disagree with FDA restrictions and a safety alert on the use...

Drug Wholesaler Charged in Massive Fraud

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Federal officials say an unsealed indictment alleges that Utah wholesale drug firm owner Randy Crowell sold $100 million in fraudu...

Guidance on Premarket Requirements for Health Care Gowns

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Federal Register Notice: FDA releases a guidance: Premarket Notification Requirements Concerning Gowns Intended for Use in Health ...

Comments Reopened on Human Genome Workshop

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Federal Register Notice: FDA reopens the comment period on a public workshop on standards-based regulatory strategy for next-gener...