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Human Drugs

Intarcia Raises NDA Advisory Committee Issues

Hogan Lovells attorney David Fox says Intarcia has several concerns about the fairness of an advisory committee meeting that the company agreed could ...

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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...

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Federal Register

Workshop on Rare Disease Endoints

Federal Register notice: FDA announces a 6/7-8 public workshop entitled Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for ...

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Federal Register

Cue Health EUA for Mpox Molecular Test

Federal Register notice: FDA announces the issuance of an emergency use authorization to Cue Health for the Cue Mpox (Monkeypox) Molecular Test.

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Human Drugs

Panel Backs Rexulti for Alzheimers Agitation

A joint advisory committee meeting votes 9 to 1 that an Otsuka Pharmaceutical and Lundbeck a sNDA for Rexulti (brexpriprazole) provided sufficient dat...