Quality Systems

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).

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.

Quality Quartets in Risk-Based Qualification

May 02, 2023

Quality Quartet Registers connect Quality Quartets to their process system or unit operation “parent.”

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.

Measuring Quality in a Culture

May 02, 2023

The concept of quality culture and how to enforce it are being debated by regulators and industry, says Siegfried Schmitt, vice president, Technical at Parexel.

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.

Protecting the NHS from Cyber Attacks

May 02, 2023

A strategy on cyber resilience for health and social care organizations has been set out by the UK government.