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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...

Amgen Wins Injunction in Biosimilar Case Against Apotex

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Amgen wins a preliminary injunction against Apotex over notification of when Apotex intends to market its biosimilar version of Ne...

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.

Compounding Pharmacys FDA-483, Response Released

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Federal Register Notice: FDA releases a draft guidance: Best Practices for Communication Between IND Sponsors and FDA During Drug ...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