Regulatory Affairs Professionals Society

FDA drafts guidance on using next-generation sequencing to assess gene therapy safety

The US Food and Drug Administration (FDA) has released draft guidance on how sponsors can utilize next-generation sequencing ...
Regulatory Affairs Professionals Society

Recon: FDA narrows search for new CBER director; Novo enters drug discovery pact with OpenAI

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

Høeg touts FDA efforts to speed rare disease drugs to market

The top drug regulator at the US Food and Drug Administration (FDA) said the agency is working to develop new pathways for ...