Guidance & Policy

Guidance & Policy FDA Launches Rare Disease Drug Review Framework Oct 19, 20266 min read Read the story Guidance & Policy FDA Sets Jan. 2027 Cutoff to Reject Bad eCTD Submissions Oct 18, 20265 min read Read the story Guidance & Policy MHRA Publishes Strategy 2030 for the AI Era Oct 16, 20266 min read Read the story Guidance & Policy FDA Raises Device User Fees About 10% for FY2027 Oct 14, 20265 min read Read the story Spotlight icotec Wins Medicare Add-On Payment for CMORE CT Oct 13, 20266 min read Read the story For Physicians NY Declares Measles Emergency, Widens Who Can Vaccinate Oct 10, 20268 min read Read the story Guidance & Policy FDA Finalizes Biosimilar Manufacturing-Change Rules Oct 10, 20266 min read Read the story Guidance & Policy FDA Eases 510(k) Rule for Federal Drug-Test Devices Oct 9, 20266 min read Read the story Guidance & Policy FDA Finalizes Class II Rule for Hyperoxia Monitors Oct 9, 20266 min read Read the story Guidance & Policy UK Backs All 44 Recommendations for NHS AI Oct 7, 20266 min read Read the story Guidance & Policy FDA Opens a 510(k) Path for Cancer Gene Panels Oct 7, 20265 min read Read the story Guidance & Policy Court Sets Oct. 7 Deadline for FDA Mifepristone Review Oct 6, 20267 min read Read the story Guidance & Policy EU Council Adopts Pharma Package, Sends to Parliament Oct 5, 20266 min read Read the story Guidance & Policy FDA's CDRH Flags AI and Surgical Robots for FY2027 Oct 4, 20264 min read Read the story Guidance & Policy Canada's New Controlled Substances Rules Take Effect Oct 4, 20264 min read Read the story Guidance & Policy EMA, MHRA Lead Call for Animal-Testing Alternatives Oct 2, 20265 min read Read the story Spotlight EBR Systems Wins Medicare Pay Rise for Its WiSE Heart Device Oct 1, 20266 min read Read the story Guidance & Policy EU's IVDR Class C Notified-Body Deadline Passes Sep 30, 20267 min read Read the story Guidance & Policy CMS Ends Breakthrough Devices' Medicare Fast Track Sep 30, 20267 min read Read the story For Physicians CMS Ends TAVR's Mandatory Two-Operator Rule Sep 29, 20269 min read Read the story Guidance & Policy TGA Sues BioV8 Directors Over Illegal Peptide Ads Sep 29, 20267 min read Read the story Guidance & Policy FDA and MDIC Meet to Set Device Science Priorities Sep 28, 20265 min read Read the story Guidance & Policy FDA Nominee Overton Grilled on Mifepristone, Vaccines Sep 27, 20265 min read Read the story Guidance & Policy FDA Drafts First Guidance for Surgical Robots Sep 26, 20266 min read Read the story Guidance & Policy MHRA Funds Four New Regulatory Science Centres Sep 24, 20265 min read Read the story Guidance & Policy TGA Bars New Andrographis Listings Over Anaphylaxis Sep 23, 20266 min read Read the story Guidance & Policy FDA Swaps 'Animal Testing' for 'Nonclinical' in Rules Sep 22, 20265 min read Read the story Guidance & Policy FDA Drafts an eSTAR Template for Device PMAs Sep 20, 20265 min read Read the story Guidance & Policy FDA Denies Bid to Exempt Radiology AI From 510(k) Sep 18, 20265 min read Read the story Guidance & Policy FDA Hears Fight Over Who Can Give Psychedelic Therapy Sep 15, 20265 min read Read the story Guidance & Policy FDA's CDRH Launches Rare Disease Device Initiative Sep 13, 20265 min read Read the story Guidance & Policy FDA Names Permanent CDER, CBER Chiefs, New AI Post Sep 12, 20265 min read Read the story Guidance & Policy EMA Extends PV Inspections to Cover Subcontractors Sep 12, 20264 min read Read the story Guidance & Policy MHRA Panel Proposes 'L-Plates' for AI in Healthcare Sep 12, 20264 min read Read the story Guidance & Policy FDA Eases Compounding Rules for Newborn IV Nutrition Sep 11, 20265 min read Read the story Guidance & Policy FDA Authorizes New JUUL2 E-Cigarette System Aug 28, 20265 min read Read the story Guidance & Policy FDA Issues 55 New Bioequivalence Guidances for Generics Aug 25, 20265 min read Read the story Guidance & Policy FDA Recognizes 14 Updated Medical Device Standards Aug 24, 20265 min read Read the story Guidance & Policy FDA Finalizes Guidance on Generic Drug TE Codes Aug 23, 20266 min read Read the story Guidance & Policy FDA Finalizes FAQ Guide for Cell, Gene Therapies Aug 23, 20266 min read Read the story Guidance & Policy FDA Revises Guidance on ANDA vs. 505(b)(2) Filings Aug 20, 20265 min read Read the story Guidance & Policy FDA Eases Path for Cancer Companion Diagnostics Aug 19, 20265 min read Read the story Guidance & Policy MHRA Clarifies UK Path for Microbiome Medicines Aug 19, 20265 min read Read the story Guidance & Policy FDA Weighs a Competency Test for AI Medical Devices Aug 19, 20265 min read Read the story Guidance & Policy FDA's GDUFA IV Plan Would Raise Foreign Drug Fees Aug 18, 20265 min read Read the story Guidance & Policy MHRA to Require Briefing Documents for Scientific Advice Aug 17, 20265 min read Read the story Guidance & Policy FDA Sets September Meeting on PDUFA VIII Fee Deal Aug 16, 20265 min read Read the story Guidance & Policy FDA Drafts New Guidance on Drug Container Closures Aug 15, 20265 min read Read the story Guidance & Policy FDA Widens Type D Meetings, Narrows INTERACT Use Aug 14, 20265 min read Read the story Manufacturing & Quality FDA Launches Council to Overhaul Its Inspections Aug 3, 20266 min read Read the story Clinical Trials MHRA Plans a 14-Day First Review for Phase 1 Trials Aug 4, 20265 min read Read the story Guidance & Policy FDA Reopens Comment Period on Title 21 Terminology Rule Aug 3, 20264 min read Read the story Guidance & Policy FDA Drafts Rules for Biosimilar Autoinjectors, Syringes Aug 3, 20265 min read Read the story Guidance & Policy FDA Finalizes Adhesion Rules for Generic Skin Patches Aug 2, 20265 min read Read the story Clinical Trials FDA Finalizes Three Cancer Trial Eligibility Guidances Jul 30, 20265 min read Read the story Guidance & Policy MHRA Draws the Line on AI Scribes as Medical Devices Jul 29, 20265 min read Read the story Guidance & Policy FDA Gives Home COVID Tests a Permanent Class II Address Jul 27, 20265 min read Read the story Manufacturing & Quality FDA Publishes Its Playbook for Fast-Track CMC Readiness Jul 26, 20265 min read Read the story Guidance & Policy Brussels Says Only Manufacturers May Assign a Device's UDI Jul 24, 20265 min read Read the story Guidance & Policy FDA Can Now Ask the Public for OTC Monograph Data Jul 17, 20265 min read Read the story Guidance & Policy FDA Retires a 1995 Guidance on Topical Steroids Jul 17, 20265 min read Read the story Guidance & Policy MDUFA VI: The Draft Deal Is Out, With a Faster 510(k) Clock Jul 16, 20266 min read Read the story Manufacturing & Quality FDA Would Let Distributed Manufacturers Register Once Jul 16, 20266 min read Read the story Guidance & Policy FDA's OTC Monograph Meetings Guidance Is Final Jul 16, 20265 min read Read the story Clinical Trials FDA's Psychedelics Guidance Is Final, After Three Years Jul 15, 20265 min read Read the story Guidance & Policy EUDAMED's Next Deadline Is Narrower Than It Looks Jul 15, 20266 min read Read the story