RAPS

HHS launches ARPA-H project to speed clinical trials

The US Department of Health and Human Services on Wednesday announced a program and funding opportunity through the Advanced Research Projects Agency for Health (ARPA-H) called 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: 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.
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

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

FDA draft guidance addresses considerations for robotically assisted surgical devices

The US Food and Drug Administration (FDA) published a draft guidance detailing its thinking on the requirements for bringing certain robotically assisted surgical devices (RASD) to market. It includes ...