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Vaccine Panel Meeting Docket No. Corrected

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Federal Register notice: FDA corrects a 4/11 notice on its Vaccines and Related Biological Products Advisory Committee that contai...

Research Describes Drug Ad Data Display

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FDA and RTI International researchers characterize data displays in prescription drug promotions to healthcare providers.

Royal Chemical Inspection Finds CGMP Violations

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FDA warns East Stroudsburg, PA-based Royal Chemical Company about CGMP violations in its manufacturing of finished drugs.

Multiple Abbott i-STAT Test Violations

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FDA warns Ottawa, Canada-based Abbott Point of Care about multiple violations in its manufacturing of the i-STAT cTnI test cartrid...

FDA OKs 2nd Covid Booster for Some People

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FDA says some elderly and immunocompromised people are now eligible for a second Moderna or Pfizer BioN/Tech Covid vaccine booster...

Lessons Learned from Rare Disease Trials During Covid

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FDA researchers describe two lessons learned from rare disease clinical trials during the Covid-19 pandemic and their applicabilit...

OND Expands Regulatory Science Research

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CDER Office of New Drugs Research Program associate director Laura Jaeger describes the regulatory science research the program ha...

EUA Granted for Azure Biotechs OTC Covid Test

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FDA issues Azure Biotech an emergency use authorization for the Azure Fastep Covid-19 Antigen Pen Home Test.

IntelGenx NDA Approved for Migraine Film

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FDA approves an IntelGenx 505(b)(2) NDA for RizaFilm VersaFilm (rizatriptan benzoate) for treating acute migraine.

BlackSwan Vascular PMA for Arterial Hemorrhage OKd

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FDA approves a BlackSwan Vascular PMA for its Lava Liquid Embolic System for treating peripheral arterial hemorrhage.