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

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

Advertising Experts Critique FDAs Increasing Enforcement

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Pharmaceutical advertising experts react to FDAs dramatically altered enforcement approach toward prescription drug promotion sinc...

Sanofi Seeks Removal of Tzield From FDA Priority Review Program

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

Brookings Economist Backs FDA Biosimilar Draft Guide

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

House Committee Would Limit Foreign Trial Data

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Five Hogan Lovells attorneys say a House Appropriations Committee report could prohibit FDA from accepting drug IND trial data fro...

10 Observations in Somerset Therapeutics FDA-483

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

New CDER Biologics Compliance Program Explained

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

Report says Makary May Face Ouster Amid White House Tensions

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

One-Day Inspection Pilot Underway at FDA

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FDA launches a pilot program using one-day inspectional assessments as part of a broader effort to modernize its oversight model a...

Makary Touts Hiring Push, Clinical Trial Reforms at FDLI

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FDA commissioner Marty Makary says the agency is undertaking a major hiring push and a series of operational reforms aimed at stre...