Regulatory and Standard Setting Organizations Directory
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
Read this article in Pharmaceutical Technology's Regulatory Sourcebook March 2021 eBook.
Articles in this issue
It Takes a Bio/Pharma Village
Enabling the Virtual Human Through Physiologically-based Pharmacokinetic Modeling
Managing the Risk of Nitrosamine Impurities
Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based Strategies
Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug Development
Collaborative Efforts Address Key Data Integrity Challenges
Can FDA Reinvent Inspections
FDA 2021 Guidance Agenda Sees Focus on Generics
A Real-World Approach to Evaluating Cleanroom Garments
Resources, Guidelines, and Guidance Documents Directory
Regulatory and Standard Setting Organizations Directory
Recent Videos
Related Content
FDA Approves Novartis Oral Treatment for Adults with C3 Glomerulopathy
March 25th 2025Article
Fabhalta (iptacopan) received a positive opinion for treatment of C3G from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and has been approved twice before by FDA.
