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Some Drug Price Hikes Related to FDA Safety

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Bloomberg Business says that an FDA effort to bring old unapproved drugs under modern regulation can lead to much higher prices fo...

FDA Safety Review Clears Zambons Monurol

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An FDA drug safety review of Zambons Monurol (fosfomycin) finds no new safety signals related to either parenteral or oral formula...

FDA Approves Alkermes Aristada for Schizophrenia

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FDA approves an Alkermes NDA for Aristada (aripiprazole lauroxil) extended-release injectable suspension for treating schizophreni...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites International Medical Development and MPH Nutrition.

Guide on Electronic Common Technical Document

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Federal Register Notice: FDA is making available an Electronic Common Technical Document (eCTD) Technical Conformance Guide, Versi...

Pilot Project for Drug REMS in SPL Format

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Federal Register Notice: FDA seeks participants in a pilot projfect for application holder of drugs with Risk Evaluation and Mitig...

Info on Generic Drug User Fees Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the generic drug user fee cover sheet to the Office o...

AdvaMed Seeks Clarification on UDI Compliance Exceptions

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Advanced Medical Technology Association says FDA should clarify that a three-year compliance date exception allowed under the Uniq...

FDA Approves McGuff ANDA for Generic Delalutin

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FDA approves a McGuff Pharmaceuticals ANDA for hydroxyprogesterone caproate injection USP, 250 mg/mL (1.25 g/5 mL vials), a generi...

BMS Settles SEC Charges Over China Misconduct

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Bristol-Myers Squibb agrees to settle charges that a joint venture in China made cash payments and provided other benefits to heal...