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 ...
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

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 ...
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

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: EU officials tout pending pharmaceutical reforms

Officials from the European Commission and European Medicines Agency (EMA) touted key reforms presented in the proposal to ...
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 ...
RAPS

Convergence: Regulators emphasize need for harmonized approach to AI

Junyang Wang moderated a panel on AI with Gabriel Innes, Luis Correia Pinheiro, and Martin Heitmann at RAPS Convergence 2026. (credit: Ferdous Al-Faruque) CHARLOTTE, NC — Regulators and industry ...