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

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

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

IMDRF releases guidance on choosing and evaluating suppliers

The International Medical Device Regulators Forum (IMDRF) has released a guidance for manufacturers on how to choose, ...
Regulatory Affairs Professionals Society

Euro Convergence: Regulators discuss new pharma legislation, AI, and more

A panel of European regulators answered questions during a town panel discussion at RAPS Euro Convergence 2026 on the ...
Regulatory Affairs Professionals Society

Recon: Makary to resign as FDA commissioner; EU reaches draft deal on Critical Medicines Act

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
RAPS

FDA looks to repurposing older drugs for new uses

The US Food and Drug Administration (FDA) is asking for input on repurposing older drugs for new therapeutic uses to address unmet medical needs across a wide range of therapeutic areas. FDA said that ...
RAPS

Trump confirms Makary is out at FDA

President Donald Trump on Tuesday confirmed that Marty Makary, Commissioner of the US Food and Drug Administration (FDA), is leaving the agency. He also announced on Truth Social that Kyle Diamantas, ...