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FDA General

House Oversight Panel Puts Heat on FDA Over CBD

House Committee on Oversight and Accountability chairman James Comer begins probe into FDAs recent decision not to regulate cannabidiol products as di...

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Federal Register

Info Collection Extension on Cell/Tissue Products

Federal Register notice: FDA announces an opportunity for public comments on an information collection extension entitled FDA Human Cells, Tissues, an...

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Federal Register

Vaccine Panel Meeting Docket No. Corrected

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

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Research Describes Drug Ad Data Display

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

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Human Drugs

Royal Chemical Inspection Finds CGMP Violations

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

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Medical Devices

Multiple Abbott i-STAT Test Violations

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

Biologics

FDA OKs 2nd Covid Booster for Some People

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

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Human Drugs

Lessons Learned from Rare Disease Trials During Covid

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

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Human Drugs

OND Expands Regulatory Science Research

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

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Human Drugs

EUA Granted for Azure Biotechs OTC Covid Test

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