Regulatory Oversight and Compliance

Pharma-PBM Battles Escalates on Capitol Hill

May 12, 2023

Congress have initiated a range of legislative proposals to further manage PBMs and the pharma market.

EC Authorizes Fabry Disease Treatment

May 11, 2023

EC has granted marketing authorization to Chiesi Global Rare Diseases and Protalix BioTherapeutics for PRX-102 (pegunigalsidase alfa).

New Guidance Effective Immediately for Testing of Glycerin, Propylene, Other High Risk Drug Components

May 10, 2023

The guidance is to provide information on compliance with applicable regulatory requirements and recommendations.

Europe Lifts COVID-19 Business Continuity Status

May 10, 2023

EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.

FDA Approves First RSV Vaccine

May 10, 2023

GSK’s Alexvy vaccine is the first to receive FDA approval for respiratory syncytial virus.

ICH Q9(R1) Quality Risk Management Guidance Document Available

May 08, 2023

The recent revision is intended to provide guidance on QRM principles and tools that can be used for different aspects of pharmaceutical quality.

High-Quality Communication Enables High-Quality Drug Products

May 02, 2023

User fee programs have improved FDA’s approval timeline for important therapies.

Optimizing the Manufacture of Emerging Therapies

May 02, 2023

Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.

FDA Gives Guidance for Decentralized Clinical Trials for Drugs, Devices

May 02, 2023

This specific guidance refers to a DCT as a clinical trial where some or all the trial-related activities occur at locations other than traditional clinical trial sites.

FDA and Industry Prepare for End to COVID-19 Emergency

May 02, 2023

FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.