Regulatory Affairs Professionals Society

FDA continues its crackdown on drug advertising with three untitled letters

Office of Prescription Drug Promotion (OPDP) has stepped up its enforcement efforts regarding prescription drug promotion, ...
Regulatory Affairs Professionals Society

FDA official: Data quality is key to plausible mechanism framework

A US Food and Drug Administration (FDA) official acknowledged significant regulatory hurdles in the development of products ...
Regulatory Affairs Professionals Society

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

The new member-exclusive RAPS Journal of Regulatory Affairs, a bimonthly, peer-reviewed publication building on the success ...
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 ...
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The US Food and Drug Administration (FDA) has released draft guidance on how sponsors can utilize next-generation sequencing ...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

Asia-Pacific Roundup: India decriminalizes compliance breaches, replacing imprisonment with fines

Indian lawmakers have voted to decriminalize some compliance breaches to reduce regulatory litigation burden, eliminating the ...
Regulatory Affairs Professionals Society

Recon: FDA denies Replimune’s cancer drug over trial issues; Revolution’s cancer pill boosts survival in Phase 3 trial

Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, ...
Regulatory Affairs Professionals Society

FDA nudges sponsors, researchers to publish trial results

The US Food and Drug Administration (FDA) has notified more than 2,200 medical product manufacturers and researchers to ...
Regulatory Affairs Professionals Society

IMDRF drafts framework on best practices for using AI in medical devices

The International Medical Device Regulators Forum (IMDRF) has released a draft technical document to create a harmonized set ...
Regulatory Affairs Professionals Society

This Week at FDA: FDA proposes FY27 budget, rejects software petition; and former CDRH leaders launch venture capital fund

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
Regulatory Affairs Professionals Society

FDA warning letters target marketers of unapproved weight loss drugs

In the latest tranche of published warning letters, the US Food and Drug Administration (FDA) has continued to go after ...
RAPS

New York/New Jersey Area Chapter Workshop: Applying Generative AI Responsibly in Regulatory Affairs

Join expert speakers and seasoned professionals for an all-day, hands-on workshop where you’ll explore real-world applications of Artificial Intelligence from analysis in support of regulatory ...