UK MHRA: European Commission Decision Reliance Procedure (EC DRP) Extension
EMA Guidance: Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources
MHRA Guidance: Good Clinical Practice for Clinical Trials
USFDA Guidance: Clinical Investigations of Medical Products Involving Children
USFDA Guidance: Distribution of Approved Naloxone Products -Immediately-in-Effect
Artificial Intelligence in Regulatory Affairs
UK MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)
USFDA Guide: Updated eCTD 4.0 - TECHNICAL CONFORMANCE GUIDE,
Swissmedic Guidance: eDok Submission Update
ICH Guidance: Q3D(R2) ELEMENTAL IMPURITIES
Indian Pharmacopoeia Commission (IPC) Joins Pharmacopoeial Discussion Group for Global Expansion
USFDA: Annual Summary Reporting Requirements -Right to Try Act -Final Rule
Health Canada: Udated Register of Innovative Drugs
USFDA Guidance: Submitting Documents Using Real-World Data & RW Evidence for Drug & Biologics
USFDA Guidance: Content & Format of Labeling for Non-Prescription Drugs, Quantitative Labeling
USFDA Guidance: Clinical Pharmacology Considerations for Pediatric Studies of Drugs & Biologics
IRIS Updated Guide: How to Create & Submit Scientific Applications & Accelerating Clin. Trials Plan
Singapore HSA: Safety Alert for Finasteride and Potential Risk of Suicidal iIdeation
EMA Guidance: For Applicants/MAHs involved in GMP and GCP Inspections
Health Canada Recommendations: ICH Q3D(R2) Guideline for Elemental Impurities