Top Industry News
- Health Canada- Validation Rules for Regulatory Transactions Provided to Health Canada in the “non-eCTD electronic-only” Format
- FDA- Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements (updated)
- Australia Looks to Improve Generic Drug Authorization Process
- EMA- New Safety Features for Medicines Sold in the EU
- HPRA Update on Safety Features Implementation for MaHs
- ANVISA- Guide guides on Regulatory Impact Analysis
- FDA- Principles of Premarket Pathways for Combination Products
- Swissmedic- Adaptation of Various Registration Documents
- ANVISA- New Resolution Published for Radiopharmaceuticals
- MHRA- No Deal Brexit Advice: Guidance on Food and Drink Labelling
- Ireland- New National Roadmap for Consumer Protection in Relation to Food Safety
Mergers & Acquisitions
- Trice Medical acquires SegWAY™ Orthopaedics
- Kerecis to acquire Swiss Life-Science Company Phytoceuticals
- Heritage Pharma Labs Inc. Announces acquisition of 23 FDA-Approved ANDAs
- Arrevus Finalizes acquisition of Fusidic Acid (Taksta™) from Melinta Therapeutics
- Teledyne Completes acquisition of Scientific Imaging Businesses of Roper Technologies
- Resonetics Announces acquisition Of Caribou Technologies