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FDA Sets Review Period for Raxibacumab

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Federal Register Notice: FDA determines the regulatory review period for Human Genome Sciences Raxibacumab for the purpose of pate...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Drbrandtskincare.com Cosmetic Dermatology, Episciences, Miracle in the Green, an...

DC Law Firm Hires Former FDA Attorney

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Hyman, Phelps & McNamara (HPM) hires former FDA attorney Melisa M. C. Moonan to advise clients on medical device regulatory issues...

FDA Launching precisionFDA Portal

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FDAers Taha Kass-Hout and Elaine Johanson say the agency is starting its precisionFDA online portal to help researchers improve th...

Firm Selling Unapproved New Drugs

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FDAs Florida District Office warns Cosmetic Dermatology that its Web site is marketing as cosmetics many products that are conside...

Guidance on West Nile Virus Tests

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Federal Register Notice: FDA releases a draft guidance document: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of W...

Guidance on Glaucoma Surgical Devices

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Federal Register Notice: FDA releases a guidance: Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Dev...

Workshop on Warfarin Therapy Monitors

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Federal Register Notice: FDA plans a public workshop 1/25/16 entitled Point of Care Prothrombin Time/International Normalized Rati...

Review Period Set for Trivascular Stent Graft System

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Federal Register Notice: FDA determines the regulatory review period for the Trivascular Ovation Abdominal Stent Graft System for ...

Review Period Set Vizamyl

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Federal Register Notice: FDA determines the regulatory review period for GE Healthcares Vizamyl for the purpose of patent extensio...