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: 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 ...
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

Euro Roundup: EMA officials argue against making single pivotal trials the ‘rigid, default position’

Emer Cooke and other EMA leaders have weighed into the debate about whether sponsors should run one or two pivotal trials, arguing that the decision should be informed by the evidence needed to show a ...
RAPS

Sponsored Webcast: How to Validate AI Under FDA's Computer Software Assurance Guidance (On-Demand)

This webinar will walk you through how to apply the FDA's CSA's risk-based principles to AI, and what that looks like in practice, using a validated requirement conflict detection AI agent as a ...