Coverage

Guidance

Every Guidance story we’ve published, newest first — each one sourced to the primary record.

All coverage

25 stories

Guidance

FDA Issues 55 New Bioequivalence Guidances for Generics

Aug 25, 20265 min read

Devices

FDA Recognizes 14 Updated Medical Device Standards

Aug 24, 20265 min read

Guidance

FDA Finalizes Guidance on Generic Drug TE Codes

Aug 23, 20266 min read

FDA

FDA Finalizes FAQ Guide for Cell, Gene Therapies

Aug 23, 20266 min read

Guidance

FDA Revises Guidance on ANDA vs. 505(b)(2) Filings

Aug 20, 20265 min read

Clinical

MHRA Clarifies UK Path for Microbiome Medicines

Aug 19, 20265 min read

Devices

FDA Weighs a Competency Test for AI Medical Devices

Aug 19, 20265 min read

Guidance

MHRA to Require Briefing Documents for Scientific Advice

Aug 17, 20265 min read

Guidance

FDA Sets September Meeting on PDUFA VIII Fee Deal

Aug 16, 20265 min read

Guidance

FDA Drafts New Guidance on Drug Container Closures

Aug 15, 20265 min read

Guidance

FDA Widens Type D Meetings, Narrows INTERACT Use

Aug 14, 20265 min read

Manufacturing

FDA Launches Council to Overhaul Its Inspections

Aug 3, 20266 min read

Clinical

MHRA Plans a 14-Day First Review for Phase 1 Trials

Aug 4, 20265 min read

Clinical

MHRA’s ILAP Passports Go to Liver Cancer, Dementia Drugs

Aug 4, 20265 min read

Guidance

FDA Drafts Rules for Biosimilar Autoinjectors, Syringes

Aug 3, 20265 min read

Guidance

FDA Finalizes Adhesion Rules for Generic Skin Patches

Aug 2, 20265 min read

Guidance

FDA Finalizes Three Cancer Trial Eligibility Guidances

Jul 30, 20265 min read

Devices

MHRA Draws the Line on AI Scribes as Medical Devices

Jul 29, 20265 min read

Devices

FDA Gives Home COVID Tests a Permanent Class II Address

Jul 27, 20265 min read

Manufacturing

FDA Publishes Its Playbook for Fast-Track CMC Readiness

Jul 26, 20265 min read

EU MDR & IVDR

Brussels Says Only Manufacturers May Assign a Device’s UDI

Jul 24, 20265 min read

FDA

FDA Can Now Ask the Public for OTC Monograph Data

Jul 17, 20265 min read

Guidance

FDA Retires a 1995 Guidance on Topical Steroids

Jul 17, 20265 min read

Guidance

FDA’s OTC Monograph Meetings Guidance Is Final

Jul 16, 20265 min read

FDA

FDA’s Psychedelics Guidance Is Final, After Three Years

Jul 15, 20265 min read