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

Asia-Pacific Roundup: Singapore’s HSA forges regulatory alliances across Africa, Asia, and Europe

Singapore’s Health Sciences Authority (HSA) has expanded regulatory reliance and cooperation activities with partners in ...
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 ...
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: 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

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

Recon: Experts press FDA to set safety, access standards for psychedelic drugs; GSK to shut German vaccine factory due to low demand

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: 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

Convergence: EU officials tout pending pharmaceutical reforms

Officials from the European Commission and European Medicines Agency (EMA) touted key reforms presented in the proposal to ...
Regulatory Affairs Professionals Society

Recon: Senate hearing set for FDA nominee; Novo partners with Anthropic for AI drug development

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

FDA warns Bausch and Lomb, Indian API maker for GMP issues

The US Food and Drug Administration (FDA) recently issued warning letters to ophthalmic product maker Bausch and Lomb and an Indian active pharmaceutical ingredient (API) maker for violations of good ...
Regulatory Affairs Professionals Society

Euro Roundup: MHRA commission makes recommendations on AI regulatory framework in the UK

A commission set up by the Medicines and Healthcare products Regulatory Agency (MHRA) has shared 44 recommendations about the ...