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

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The US Food and Drug Administration (FDA) has released draft guidance on how sponsors can utilize next-generation sequencing ...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

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

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

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

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, ...
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 ...
Regulatory Affairs Professionals Society

Study: Most bispecific antibodies lack postapproval improvements to overall survival, quality of life

Many of the bispecific antibodies (BsAbs) approved by global regulators have yet to demonstrate robust clinical benefit ...
Regulatory Affairs Professionals Society

Euro Roundup: EMA group recommends actions to accelerate regulatory science research

A European Medicines Agency (EMA) group has recommended actions the regulator and industry can take to accelerate regulatory ...
Regulatory Affairs Professionals Society

Recon: Novo to offer discount Wegovy subscription for self-pay US consumers; Lilly to acquire Centessa in deal worth up to $7.8B

Recon: Novo to offer discount Wegovy subscription for self-pay US consumers; Lilly to acquire Centessa in deal worth up to $7.8B Join one of the many groups where you can pursue your regulatory ...
RAPS

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 drugmakers for marketing glucagon-like peptide-1 (GLP-1) receptor agonists and ...