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Blackfynn Adds Hahn to Company Board

[ Price : $8.95]

Former FDA commissioner Stephen Hahn joins clinical therapeutics startup Blackfynns board of directors.

Info Collection of Device Shortages Data

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for Shortages Data Collections.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include CooperSurgical and Dr. Paul's Lab.

GSK Wants Changes to OTC Drug Naming Guidance

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GSK Healthcare asks FDA to change its approach in a draft guidance on labeling OTC drugs.

Pacific Stem Cells Selling Unapproved Products: FDA

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FDA says Pacific Stem Cells is marketing unapproved stem cell products to treat several diseases and conditions.

Study Finds Lack of Minority Groups in Vaccine Trials

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A new study finds that racial/ethnic minority groups and older adults are underrepresented in U.S.-based vaccine clinical trials.

Info Collection on GMPs for Blood and Components

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Federal Register notice: FDA seeks comments on an information collection extension entitled Current Good Manufacturing Practices a...

Info Collection on Blood Cell Separator Guidance

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Federal Register notice: FDA seeks public comments on an information collection extension associated with its Guidance for Industr...

Info Collection Extension for CVM Dispute Resolution

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Federal Register notice: FDA sends to OMB an information collection extension entitled Dispute Resolution Procedures for Science-B...

AstraZenenca Withdraws Imfinzi Bladder Cancer Use

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AstraZeneca withdraws an Imfinzi (durvalumab) indication, treating previously treated adult patients with locally advanced or meta...