Regulatory Affairs Professionals Society

Euro Convergence: Experts share insights on AI for submissions, conformity assessments

A panel of experts at RAPS Euro Convergence 2026 discussed how artificial intelligence (AI) is being applied throughout the ...
Regulatory Affairs Professionals Society

Recon: FDA upheaval prompts some biotechs to move early trials abroad; AZ’s Imfinzi combo boosts bladder cancer survival in late-stage trial

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Regulatory Affairs Professionals Society

Euro Roundup: EU lawmakers reach agreement on Critical Medicines Act

The European Parliament and Council have reached a provisional agreement on the Critical Medicines Act (CMA), moving ...
Regulatory Affairs Professionals Society

FDA official details top observations from QMSR inspections

The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing and ...
Regulatory Affairs Professionals Society

Asia-Pacific Roundup: Malaysia’s NPRA starts recognition procedure pilot for drugs approved by FDA and EMA

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has begun piloting a fast-track registration pathway for products ...
Regulatory Affairs Professionals Society

FDA finalizes guidance on CMC flexibilities for cell and gene therapies

The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on ...
Regulatory Affairs Professionals Society

Euro Convergence: Deliberate questions, follow-up are key to orphan device development

Orphan medical device makers should be deliberate in their questions to expert panels and ensure their post-market clinical ...
Regulatory Affairs Professionals Society

Euro Convergence: Experts weigh in on proposed MDR reforms

A panel of experts representing regulators, industry, and notified bodies gave their opinions on the proposed revision of the ...
Regulatory Affairs Professionals Society

FDA officials discuss new AI tool HALO, other applications of AI

Officials from the US Food and Drug Administration (FDA) discussed the launch of a new artificial intelligence (AI) system to ...
Regulatory Affairs Professionals Society

Euro Convergence: EU pharmaceutical overhaul brings challenges, hope for better regulation

Industry representatives, patients, and regulators shared their perspectives on the reforms to the EU pharmaceutical ...