Regulatory Affairs Professionals Society

PhRMA, Novartis weigh in on FDA’s 3-year exclusivity guidance

The Pharmaceutical Research and Manufacturers of America (PhRMA) said the US Food and Drug Administration’s (FDA) recent ...
Regulatory Affairs Professionals Society

Recon: FDA names new acting CDER, CBER heads; Supreme Court denies pharma’s challenge to IRA price negotiations

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

Asia-Pacific Roundup: TGA posts guidance on manufacturing, advertising compounded medicines

Australia’s Therapeutic Goods Administration (TGA) has released guidance on manufacturing, supplying, and advertising compounded medicines to support compliance with its regulatory requirements. TGA ...
Regulatory Affairs Professionals Society

This Week at FDA: Makary reportedly on the way out at FDA, new guidance, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
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

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

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

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

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: 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 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 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 ...