Top Industry News
- Swissmedic - Updating of guidance document and FAQ document "Authorisation Biosimilar"
- FDA finalizes guidance on waivers for bioavailability and bioequivalence studies
- CMC Changes for Biologics: FDA offers draft guidance
- EMA - Pharmacovigilance fees to rise in 2018
- FDA - eCTD Technical Conformance guide
- Medsafe - Guideline on the regulation of therapeutic products in NewZealand
- MHLW Pharmaceuticals and Medical Devices Safety Information (FY2017)