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Deadlines & Dates

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

21 stories

Regulatory News has published 21 Deadlines & Dates stories between 15 July 2026 and 19 October 2026, each sourced to the primary record — the Federal Register entry, the Official Journal notice, the guidance document or the regulator’s own release — and written and edited by Connor Griggs, the publication’s editor. Last updated 19 October 2026.

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Showing 21 of 21 stories

A senior executive smiles at the head of a boardroom table with a city skyline behind Guidance & Policy FDA Launches Rare Disease Drug Review Framework Oct 19, 20266 min read Read the story A professional holds a tablet while standing in a bright office atrium, standing in for FDA's electronic submission data-standards notice Guidance & Policy FDA Sets Jan. 2027 Cutoff to Reject Bad eCTD Submissions Oct 18, 20265 min read Read the story A businessman in glasses and a grey suit smiles in an office, with data charts pinned to the wall behind him Devices & Diagnostics WHO Expands Device Prequalification to Condoms, IUDs Oct 14, 20266 min read Read the story Federal office buildings along a Washington, D.C. street, with the Washington Monument visible in the background Guidance & Policy FDA Raises Device User Fees About 10% for FY2027 Oct 14, 20265 min read Read the story Two colleagues shake hands across a table in a bright office Clinical Trials FDA Opens Docket on Ibogaine Trial Design, Safety Oct 7, 20265 min read Read the story A man in a white shirt reviews and signs a document at a table near a bright window Guidance & Policy Court Sets Oct. 7 Deadline for FDA Mifepristone Review Oct 6, 20267 min read Read the story A clinician in a white coat examines a patient at an ophthalmic slit lamp Guidance & Policy EU's IVDR Class C Notified-Body Deadline Passes Sep 30, 20267 min read Read the story A businessman in a suit reviews a red folder open on a boardroom table Guidance & Policy CMS Ends Breakthrough Devices' Medicare Fast Track Sep 30, 20267 min read Read the story A team of colleagues reviews a chart and hands off a printed report during a planning session in a bright loft office Guidance & Policy FDA and MDIC Meet to Set Device Science Priorities Sep 28, 20265 min read Read the story Marble columns and rotunda ceiling of a neoclassical government building, viewed from below against a blue sky Guidance & Policy MHRA Funds Four New Regulatory Science Centres Sep 24, 20265 min read Read the story 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