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Comments Sought on Blood Establishment Regs

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Federal Register Notice: FDA seeks comments on information collection requirements related to blood establishment registration and...

FDA Sets 9/29 Review Action Date on Relistor Resubmission

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FDA sets a 9/29 user fee review action target date for a Salix Pharmaceuticals resubmitted supplemental NDA for Relistor (methylna...

Celltrion Seeks Approval for Remicade Biosimilar

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Celltrion files a 351(k) application seeking approval for Remsima, a biosimilar version of Janssen Biotechs Remicade (infliximab)....

Good Progress on Antibiotic Resistance Reported by FDA

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FDAs Center for Veterinary Medicine reports gains in lowering the incidence of foodborne antibiotic resistance, along with some wo...

Comments Sought on Influenza Pandemic Reporting Guidance

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Federal Register Notice: FDA seeks comments on a guidance on enforcing adverse event reporting requirements during an influenza pa...

Rulemaking Needed on Substantial Equivalence Changes: Law Firm

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Law firm Ropes & Gray says there are concerns that FDAs final guidance entitled the 510(k) Program: Evaluating Substantial Equival...

FDA Employees Rank FDA Lower on Best of Survey

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FDA slips in the annual agency rankings of Best Places to Work in the Federal Government.

Covis Pharma Cited for Promo Violations

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CDERs Office of Prescription Drug Promotion sends an untitled letter to Covis Pharmaceuticals over a physician letter promoting La...

FDA Hits Amarin Pharma with Promotional Violation Letter

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FDA objects to an Amarin Pharmaceuticals promotional Rapid Overview Webcast Series - Print Invitation for Vascepa (icosapent ethy...

Novo Nordisk Files NDA for Weight Management

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Novo Nordisk files an NDA with FDA for a 3 mg dose of liraglutide for chronic weight management.