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CGMP Problems Found at Dental Technologies

[ Price : $8.95]

FDAs Chicago District Office warns Dental Technologies of CGMP violations in its production of prescription drugs.

Exclusivity Not Forfeited Due to Innovator Reformulation

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K&L Gates attorneys say FDA has clarified its position on forfeiture of generic drug exclusivity in specific instances for parente...

Researcher Advancing Biodegradable Medical Devices

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University of California Bourns College of Engineering assistant professor Huinan Liu researches biodegradable materials for use i...

FDA Clears Navigator Drug Delivery System

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FDA clears a Carticept Medical 510(k) for the Navigator Delivery System, a computer-controlled drug delivery system with integrate...

Web Site Posted for Future CDRH Guidances

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Federal Register Notice: FDA posts a Web address with a list of guidance documents CDRH is considering.

FDA Clears H. Pylori Antibody

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FDA clears a Ventana Medical Systems 510(k) for the Ventana anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody for...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Aesculap, Cantor & Nissel, Dental Technologies, Electrostim, Herbal Nitro, Colum...

Report on Improving Access to Compliance/Enforcement Data

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Federal Register Notice: FDA releases a report as part of its transparency initiative, which includes eight draft proposals to mak...

ICH Prep Meeting Planned

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Federal Register Notice: FDA plans a public meeting 10/25, Preparation for ICH Steering Committee and Expert Working Group Meeting...

Columbia U. Improperly Used Radioactive Drugs: FDA

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FDA warns Columbia University Medical Center about failures of its Radioactive Drugs Research Committee to assure the safety of ra...