Guidance on Developing Drug Shortage Management Plans - France - ANSM
Pre-Authorisation Procedural Advice for Users of the Centralised Procedure - EMA
Guideline on Quality Documentation for Drug-Device Combination Products - EMA
ICH Q13 Draft Guideline reaches Step 2 of the ICH process
FDA’s revised MAPP Procedures for Generic Drug Labeling Change
Clinical Trials Information System (CTIS) Free Webinar – EMA
Final Guidance - FAR Submission: Q&A – US FDA
Guidance on Packaging for Human Medicinal Products, Med.Prod Names & eSubmissions platform - Swiss
Speedier Set Up for Clinical Research Trials – MHRA UK
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) – EMA
Final Guidance on Unique Device Identification System: Form and Content of the UDI – US FDA
MHRA Delivery Plan 2021-2023 – UK MHRA
Latest reforms to Post-Market Monitoring of Medical Devices- Australia’s TGA
Final GMP data integrity guidance– PIC/S
Draft guidance for Transdermal Adhesion Systems– US FDA
Providing Regulatory Submissions in Alternate Electronic Format – US FDA
Five Drugs as Preferred for COVID-19 Therapeutics - listed by EMA