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Compounding Pharmacys FDA-483, Response Released

[ Price : $8.95]

FDA releases an FDA-483 detailing its findings from an inspection at the Wedgewood Village Pharmacy and the companys response that...

FDA Clears DSM Bio Radiopaque Cerclage Cable

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FDA clears a DSM Biomedical 510(k) for the Dyneema Purity Radiopaque Cerclage Cable for use in orthopedic trauma treatments, such ...

Guidance on FDA-IND Sponsor Communications

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Federal Register Notice: FDA releases a draft guidance: Best Practices for Communication Between IND Sponsors and FDA During Drug ...

Comments Reopened on Genetic Tests

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Federal Register Notice: FDA reopens the comment period on a public workshop discussing the use of databases that link human genet...

Panel to Discuss Treatment for Opioid Dependence

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Federal Register Notice: FDAs Psychopharmacologic Drugs Advisory Committee will meet 1/12/16 to discuss a Titan Pharmaceuticals ND...

FDA Posts Sept, Oct NADAs, ANADAs

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Federal Register Final rule: FDA amends the animal drug regulations to reflect September and October application-related actions f...

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...