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Deadlines & Dates

Stories with a date attached: comment periods, advisory committees, hearings, user-fee meetings and action dates.

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Two masked lab researchers review notes on a clipboard while operating a microscope, surrounded by lab glassware

Drugs & Biologics FDA Extends Review of Capricor's Duchenne Therapy Aug 24, 20265 min read Read the story

A man in a suit reviews and signs a paper document at a desk, with an American flag in the background

Guidance & Policy FDA Revises Guidance on ANDA vs. 505(b)(2) Filings Aug 20, 20265 min read Read the story

The US Capitol building with its dome and colonnade under a bright blue sky

Guidance & Policy FDA's GDUFA IV Plan Would Raise Foreign Drug Fees Aug 18, 20265 min read Read the story

Two lab technicians in cleanroom garb examining a sample under a microscope in a bright diagnostics laboratory

Devices & Diagnostics FDA Sets a September Panel on GRAIL's Galleri Blood Test Aug 17, 20266 min read Read the story

A close-up of a man in a suit signing a printed document with a pen at a wooden desk

Guidance & Policy MHRA to Require Briefing Documents for Scientific Advice Aug 17, 20265 min read Read the story

A stone government building with a domed clock tower and a large American flag flying from a pole out front, under a bright blue sky

Guidance & Policy FDA Sets September Meeting on PDUFA VIII Fee Deal Aug 16, 20265 min read Read the story

Two men in suits seated with an American flag behind them, one writing on a document held on a clipboard while the other reviews papers

Drugs & Biologics FDA Grants Hearing on Generic Concerta After Decade Aug 16, 20265 min read Read the story

A row of Corinthian columns rises along the stone facade of a government office building flying American flags

Guidance & Policy FDA Reopens Comment Period on Title 21 Terminology Rule Aug 3, 20264 min read Read the story

FDA Building 66, home of the Center for Devices and Radiological Health

Guidance & Policy MDUFA VI: The Draft Deal Is Out, With a Faster 510(k) Clock Jul 16, 20266 min read Read the story

Rows of empty seats facing an FDA-branded screen in the White Oak Great Room

Drugs & Biologics FDA Sets a September Hearing on Psychedelic Therapy Jul 16, 20265 min read Read the story

The hemicycle of the European Parliament in Brussels

Guidance & Policy EUDAMED's Next Deadline Is Narrower Than It Looks Jul 15, 20266 min read Read the story