MDCG Guidance: Implementation of the Master UDI-DI Solution for Contact Lenses
EMA Guidance: Scientific Guidelines with Summary of Product Characteristics (SmPC) Recommendations
UK MHRA Issues Final Call to Comply with Windsor Framework for Medicines by January 2025
USFDA: Guidances to Advance Drug Development and Safety Assessments Advance Drug Development and Safety Assessments
USFDA MD Guidance: Enhancing Safety and Efficiency in Orthopedic Devices and Sterilization Processes
Malaysia’s Medical Device Authority (MDA) Guidance: Control of Obsolete and Discontinued Medical Devices in Healthcare or Related Facilities
USFDA Guidance: 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review
Swissmedic Guidance on Product Information for Human Medicinal Products
USFDA Guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics
UK MHRA Guidance: How Marketing Authorisation Applications referred under Article 29 are Handled
South Africa's SAHPRA: Communication to Industry on Quality Variations
Swissmedic Guidance: Combined Studies: Clinical Investigations of Medical Devices, Medicinal Products, and Advanced Therapy Medicinal Products (ATMPs)
USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications
USFDA Guidance: M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
EMA Guidance: Application of the Amended Variations Regulation from 1 January 2025
SAPHRA News: Implementation of RIMS – Information on eCTD 3.1 Module 1
Swissmedic Guidance: Fast-Track Authorisation Procedure and Temporary Authorisation for Human Medicinal Products
MDCG Guidance: MDR requirements for Legacy Devices
US FDA Draft Guidance: Drug Interaction Information in Human Prescription Drug and Biological Product Labeling
UK MHRA Guidance: Orphan Medicinal Products, Reference Medicinal Products (RMPs), and Handling of Active Substance Master Files (ASMFs) and Certificates of Suitability (CEP)