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

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

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 ...
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News & Insights Search

CHARLOTTE, NC — When former US Food and Drug Administration (FDA) Commissioner Robert Califf was a medical student in the mid-1970s, he had an opportunity to work with his mentor on one of the first ...
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

Convergence: Califf says regulations ‘need an update,’ sees AI assistants in regulatory future

Commissioner Robert Califf was a medical student in the mid-1970s, he had an opportunity to work with his mentor on one of ...
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 ...
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

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 ...