Drug Shortages Reveal GMP Concerns

Addressing human interventions to reduce their impact on contamination requires addressing broader considerations than limiting operator activities. Equipment, automation, procedural and component changes can be utilized to make the aseptic activities safer. This article offers suggestions for reducing the adverse impact of intervention throughout the aseptic process.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Artificial intelligence and machine learning can help identify complex patterns.

Sotyktu (deucravacitinib) has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.