RAPS

FDA call for new adcomm members signals renewed interest in outside advisors

The US Food and Drug Administration (FDA) has issued notices inviting subject-matter experts and consumer representatives to volunteer for its advisory committees. The move comes after the role of FDA ...
Regulatory Affairs Professionals Society

Recon: FDA approves Egetis’ Emcitate for rare genetic disease; Novo buys rights to Chinese weight-loss pill in $2.6B deal

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

Convergence: Regulators highlight efforts to streamline the European regulatory framework

A panel of regulators convened at the 2026 RAPS Convergence to discuss several initiatives underway in Europe to help ...
Regulatory Affairs Professionals Society

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

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

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 future regulatory framework for AI in the UK. MHRA created the National ...
RAPS

Convergence: Thinking past GCP compliance for regulatory acceptability of foreign trial data

CHARLOTTE, NC — Whether the US Food and Drug Administration (FDA) will accept clinical evidence from outside the United States (OUS) depends on if the investigations followed good clinical practice ...
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

Recon: Adcomm backs Grail’s cancer test; Lilly, China’s InnoCare sign $3.35B deal

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