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Human Drugs

New CDER Biologics Compliance Program Explained

Two Alston & Bird attorneys give a comprehensive analysis of the new CDER compliance program for pre-license and preapproval inspections of CDER-regul...

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FDA General

Report says Makary May Face Ouster Amid White House Tensions

Media reports suggest FDA commissioner Marty Makarys time at FDA may be limited due to White House tension over his management of the agency.

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Biologics

CBER Acting Head Highlights Regulatory Flexibility, AI and Rare Disease Priorities

CBER acting director Katherine Szarama discusses an expansive vision for the biologics center during remarks at the Food and Drug Law Institutes annua...

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Marketing

Advertising Experts Critique FDAs Increasing Enforcement

Pharmaceutical advertising experts react to FDAs dramatically altered enforcement approach toward prescription drug promotion since last fall.

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Human Drugs

Sanofi Seeks Removal of Tzield From FDA Priority Review Program

Sanofi asks FDA to remove its Type 1 diabetes therapy Tzield from the agencys National Priority Voucher review program following an internal disagreem...

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Human Drugs

Brookings Economist Backs FDA Biosimilar Draft Guide

A Brookings Institution health economist voices support for FDAs revisions to a guidance on questions and answers about biosimilar development and the...

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Human Drugs

House Committee Would Limit Foreign Trial Data

Five Hogan Lovells attorneys say a House Appropriations Committee report could prohibit FDA from accepting drug IND trial data from China, Russia, Nor...

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Human Drugs

10 Observations in Somerset Therapeutics FDA-483

FDA releases the form FDA-483 with 10 observations from a 2025 inspection at Indias Somerset Therapeutics Private Limited.

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Medical Devices

Guidance On Patient-Matched Guides for Orthopedic Implants

FDA posts a new guidance detailing how manufacturers should design and submit regulatory applications for patient-matched guides used in orthopedic im...

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Human Drugs

Expedite FDA Review of Breakthrough Mental Health Therapies: House Letter

Some 30 bipartisan House members urge FDA to expedite its review of new mental health therapies.