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FDA Concedes to Pacira in First Amendment Suit

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FDA concedes and it and Pacira Pharmaceuticals settle a First Amendment challenge over alleged off-label promotion involving Expar...

CPOE Medication Safety Report Recommendations

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A Brigham and Womens Hospital Center for Patient Safety Research and Practice white paper provides findings from its analysis of c...

Comments Sought on Bar Code Labels

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Federal Register Notice: FDA seeks comments on the bar code label requirements for drug and biological products.

Guidance on Head Lice Treatment

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Federal Register Notice: FDA releases a draft guidance for industry entitled Head Lice Infestation: Developing Drugs for Topical T...

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...

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Federal Register Notice: FDA releases a draft guidance document: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of W...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