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FDA to Research Provider Boxed Warning Perceptions

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CDERs Office of Prescription Drug Promotion says it will survey healthcare providers to learn how they receive, process, and use B...

Healthcare Providers Value Reprints: Report

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A CMI Media doctor survey shows that providers want to receive current medical news and clinical information and can access a vari...

Nonvoting Member Needed on CBER Vaccine Panel

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Federal Register notice: FDA seeks interested industry organizations to participate in selecting a nonvoting industry representati...

7 Info Collections Approved by OMB

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Federal Register notice: FDA posts a list of seven information collections that have been recently approved by OMB.

Alnylam Pharma. NDA for Givosiran Filed

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FDA accepts an Alnylam Pharmaceuticals NDA for givosiran for treating acute hepatic porphyria.

Drug Postmarketing Commitments On Track: FDA

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FDA says its FY 2018 PMR/PMC performance report shows that the majority of post-marketing requirements and commitments were succes...

Rockwell Medical NDA for Intravenous Trideric

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FDA accepts a Rockwell Medical NDA an intravenous formulation of Triferic (ferric pyrophosphate citrate) for kidney disease patien...

Mt. Derm's Exceed OK'd for Acne Scarring

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FDA clears an Mt. Derm 510(k) to expand the use of its Exceed microneedling device for treating acne scarring.

CGMP Violations at Results RNA

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FDA warns Results RNA about CGMP violations in its production of finished drugs.

FDA Hails Court Compounding Decision

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FDA praises a DC federal court decision backing the way the agency determines clinical need for bulk drug substances to be compoun...