Top Industry News
- NPRA- Implementation of Regulatory Control of API For Registered Products with Registration Expiration Starting 1 January 2020
- ANVISA Will Request Sending of Master File of Plant
- SFDA- Guidance on Optimizing Standards for Regulatory Use
- FDA Finalizes Guidance on Pediatric Information in Drug Labels
- FDA- CBER Finalizes Guidance on Use of Standards in Regulatory Submissions
- Health Canada- Filing Submissions Electronically
- EMA- New EudraVigilance System Improves Reporting of Side Effects and Detection of Safety Signals
- TGA- TGO 101, Minimum Quality Standards for Tablets, Capsules and Pills Supplied in Australia
- FDA Classifies IVDs for Bacillus Detection
- FDA Drafts Guidance on Inspections of Medical Device Establishments
- Ayurvedic Standards in India: Regulator Considers Separate Classification Within Food Supplements Regime
- TGA- Risk Management Plans for Medicines and Biologicals
- TGA- GMP Clearance Guidance Update
- European Union and ICH Guidelines Adopted in Australia
- ICH Advances Revised Guideline on Elemental Impurities
Mergers & Acquisitions
- Allergan Acquires Envy Medical, Inc.
- Thermo Fisher Scientific to Acquire Brammer Bio
- Sorrento Therapeutics Announces the Merger of Scilex and Semnur
- Boehringer Ingelheim Enhances Oncology R&D with Novel MacroDel Delivery Technology Via Acquisition of ICD Therapeutics
- Vireo Health Expands National Footprint with Acquisition of New Mexico Medical Cannabis Company