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Medical Devices

Shuren Retiring; Tarver is Acting CDRH Director

CDRH director Jeff Shuren says he is retiring later this year and deputy Center director for transformation Michelle Tarver will serve as acting direc...

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Common BIMO Violations Listed

Attorney Julie Tibbets reviews the Warning Letters issued in FY 2023 and so far in FY 2024 under the FDA Bioresearch Monitoring program.

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Human Drugs

RWD in Regulatory Decisions Guidance

FDA publishes a guidance on assessing types of medical records to provide real-world data (RWD) for drugs and biologics regulatory decision-making.

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Human Drugs

Biocon Biosphere FDA-483

FDA releases the form FDA-483 with three observations from an inspection at Biocon Biosphere in Andhra Pradesh, India.

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Human Drugs

FDA Denies Novartis Entresto Petition

FDA denies a Novartis 2022 petition seeking specific agency actions on ANDAs citing Entresto as the reference-listed drug.

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Human Drugs

Pfizer Optimistic on Hemphilia A Gene Therapy

Pfizer plans to discuss with FDA its path to seek approval of its investigational gene therapy for treating adults with moderately severe to severe he...

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Biologics

FDA Seeks Input on Biosimilar Guidance Development

FDA establishes a docket to receive information and comments on how best to advance the development of new biosimilar biological products through guid...

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Human Drugs

Telix NDA for PSMA-PET Imaging Kit

FDA accepts for filing a Telix Pharmaceuticals NDA for TLX007-CDx, a proprietary cold kit for preparing prostate-specific membrane antigen-PET imaging...

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Human Drugs

Guide on OTC Monograph eSubmissions

FDA posts a final guidance entitled Providing Over-the-Counter Monograph Submissions in Electronic Format.

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Federal Register

Mesa Bio Covid Test Authorization Revoked

Federal Register notice: FDA announces that it revoked a Mesa Biotech emergency use authorization for the Accula SARS-CoV-2 Test.