Regulatory Affairs Professionals Society

Recon: FDA staff raise no major concerns for Grail multi-cancer test ahead of adcomm; Trump admin drafting order to exert control over NIH grant funding

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

Convergence: Experts review the state of play for MDR/IVDR amid proposed reforms

A panel of experts representing the European Commission, industry, and notified bodies reviewed the state discussed the ...
Regulatory Affairs Professionals Society

This Week at FDA: Overton nomination hearing, FDA’s hiring challenges, and more

This week, a Senate committee scheduled a hearing for President Trump’s nominee to lead FDA, new reporting sheds light on the ...
RAPS

Recon: Pharma companies urge Trump administration to protect China deals; EU drugmakers seek faster trials, more spending to compete with US, China

In Focus: US Members of Congress push back on plan to create a commission of political appointees to review NIH grants (STAT) Psychedelic REMS framework must start with data standardization, ...
Regulatory Affairs Professionals Society

FDA to test new approach to expediting Phase 1 trials

The US Food and Drug Administration (FDA) announced on Tuesday the launch of a pilot program designed to expedite the review ...
Regulatory Affairs Professionals Society

Convergence: Achieving representative enrollment in clinical trials

Officials from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and industry representatives ...
Regulatory Affairs Professionals Society

Convergence: Experts discuss the past, present, and future of regulatory

Experts in medical device and pharmaceutical regulatory affairs discussed how the field has evolved over the last five ...
Regulatory Affairs Professionals Society

EMA guideline addresses concerns with potential drug interactions in the GI tract

The European Medicines Agency (EMA) has published a guideline on evaluating drug interactions in the gastrointestinal tract ...
RAPS

FDA nominee Overton faces grilling in Senate confirmation hearing

Heidi Overton, President Donald Trump’s nominee to lead the US Food and Drug Administration (FDA), faced questions from both sides of the political aisle about her views on hot-button issues facing ...
Regulatory Affairs Professionals Society

Convergence 2026: Shaping the next 50 years of regulatory

RAPS Convergence 2026 is an opportunity for regulatory professionals to reflect on the evolution of the profession, look ...