Top Industry News
- ANVISA Approves Public Consultation on Biosimilar Medicines
- MHRA Labelling and Packaging of Medicinal Products for Human Use Following Agreement of the Windsor Framework
- HAS Implementation of Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) manufacturers
- FDA Electronic Submission Template for Medical Device 510(k) Submissions
- GMP Compliance Inspection Concerning Drugs and Quasi-drags of Foreign Manufacturers(Overview Guidance for Foreign Drugs Manufacturers)
- The Northern Ireland MHRA Authorised Route (NIMAR)
- MHRA Guidance on UK-wide Licensing for Human Medicines
- Swissmedic Revision of MedDO and IvDO
- FDA Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption
- USA – Review 'Cosmetics Direct' for Registration & Listing of Cosmetics!
- Swissmedic Adaptation of the Guidelines Formal Requirements
- Ministry of Food and Drug Safety Unveils Guide for Personalized Nutritional Supplements Development
- Guidance on SFDA Requirements for Quality Assurance Programs for Radiation Emitting and Imaging Devices (MDS-G15)
- FDA Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
- WTO Update: Food Safety Ordinance Amendment Addresses Import and Supply Restrictions on Japanese Food Products in Hong Kong Amid Fukushima Concerns
- CBER Revises Internal Procedures for Processing Clinical Holds, NDAs and BLAs
- FDA Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology
- Draft Guidance Released by FDA for Cosmetic Product Facility and Product Registration and Listing
- FDA Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling
- FDA Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”
- ANVISA Deliberates on the Classification of Dietary and Table Sweeteners
- NMPA Holds Training on Internal Review of Vaccine Regulatory Quality Management System
- Publication of the Agency's 2023 Draft Recommendation for REACH Annex 14 (Authorisation List) - Diisohexyl Phthalate (DIHxP)
- Extension of Temporary Record-Keeping Provisions for NICNAS Introducers until April 1, 2024
- EFPIA: EU Pharma Manufacturing Would ‘grind to a halt’ Under Proposed PFAS Ban