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Top Industry News
- FDA Guidance on Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products
- MHRA Impact of AI on The Regulation of Medical Products
- MHRA Send and Receive Information on Adverse Drug Reactions (ADRs)
- EMA Meeting Highlights From the Committee for Veterinary Medicinal Products (CVMP) 16-18 April 2024
- SFDA Registration According to Verification and Abridged
- ANVISA Will Prepare CP for Regulation on Clinical Trials for Drug Registration
- MHRA Impact of AI on the Regulation of Medical Products
- SFDA Breakthrough Medicine Program
- FDA Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564
- FDA Draft Guidance on Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products
- ANVISA Will Use Analysis from Equivalent Foreign Authorities for the GMP Inspection and Certification Process
- The European Commission Updates Cosmetic Regulation with Addition of Nine New Ingredients
- UAE Releases GCC Technical Regulation for Dried Figs to Ensure Quality and Safety Standards
- MHRA’s AI Regulatory Strategy Ensures Patient Safety and Industry Innovation into 2030
- Uruguay Launches Public Consultation on MERCOSUR Resolution Amendments for Food Additives"
- European Commission Issues Amendment to Regulation on Hygiene Requirements for Meat, Fish, Dairy, and Eggs
- CFSA Seeks Input on Novel Food Raw Materials: Nannochloropsis Oil, Egg Yolk Phospholipid, and Rye Pollen
- SCCS - Preliminary Opinion Open for Comments on Triphenyl Phosphate (CAS No. 204-112-2, EC No. 115-86-6) - Deadline: 2 June 2024
- FSANZ Announces Amendments to Processing Aid Regulations for Food Standards in Australia and New Zealand
- The European Commission Establishes Guidelines for Restricting the Use of the Most Hazardous Chemicals to Essential Purposes
- FDA Draft Guidance on Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs
- SFDA Regulations and Requirements for the Clearance of Medicines, Pharmaceutical Products, Medical Devices, and Food Products that Arrive for Pilgrims Use
- FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests
- EMA ETF Recommends Updating COVID-19 Vaccines to Target New JN.1 Variant
- FDA Draft Guidance on CVM GFI #287 - Raw Data for Safety and Effectiveness Studies
Mergers & Acquisitions
- Deciphera Pharmaceuticals to be Acquired by ONO Pharmaceutical For $2.4 Billion
- ONO Enters into a Definitive Agreement to Acquire Deciphera Pharmaceuticals
- Mariana Oncology to be Acquired by Novartis to Advance Precision Radiopharmaceuticals to Treat Cancer
- Sentynl Therapeutics Announces Global Acquisition of Zokinvy® (Lonafarnib) for Treatment of Hutchinson-Gilford Progeria Syndrome from Eiger BioPharmaceuticals
- Harmony Biosciences Acquires Epygenix Therapeutics, Inc., Adding Late-Stage Epilepsy Franchise to Growing Pipeline of Innovative CNS Assets
- Quest Diagnostics to Acquire PathAI Diagnostics to Accelerate AI and Digital Pathology Adoption in Cancer Diagnosis; Forms Licensing Agreements with PathAI