Regulatory Affairs Professionals Society

Experts: Specialized AI has great potential for regulatory, needs SME oversight

BARCELONA – Experts said that specialized artificial intelligence (AI) tools can be invaluable in helping companies address ...
Regulatory Affairs Professionals Society

Recon: FDA shelves commissioner's voucher program; Eli Lilly gets first GLP-1 weight-loss pill approved in China

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

FDA seeks input on addressing patient-level data challenges for RWD/RWE

The US Food and Drug Administration (FDA) is requesting feedback on possible solutions that would help sponsors more ...
Regulatory Affairs Professionals Society

Euro Roundup: EMA posts draft guideline on approval dossiers for biomarker-guided therapies

The European Medicines Agency (EMA) is seeking feedback on the information needed for the approval of biomarker-guided ...
Regulatory Affairs Professionals Society

FDA issues draft guidance on early-phase IND studies for solid tumors

The US Food and Drug Administration (FDA) has issued draft guidance to assist sponsors in developing early-phase ...
Regulatory Affairs Professionals Society

Recon: Bayer wins FDA approval for stroke prevention drug; Third Rock enters $2B partnership with AI-focused Chinese biotech

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

FDA Commissioner touts strong interest in early-stage trial pilot

Commissioner Kyle Diamantas said there is significant public interest in its recently announced Expedited Investigational New ...
Regulatory Affairs Professionals Society

FDA official expects user fee reauthorization despite midterm shakeup

A top US Food and Drug Administration (FDA) official stated that the midterm congressional election results will not likely ...
Regulatory Affairs Professionals Society

Regulatory intelligence requires critical thinking, actionability to be valuable, experts say

A panel of experts said that while technologies such as artificial intelligence (AI) can help aggregate and process vast ...
RAPS

FDA slashes number of analytical tests for IVDs used in public health emergencies

The US Food and Drug Administration (FDA) on Monday finalized guidance to assist manufacturers in validating in vitro diagnostic devices (IVDs) that test for emerging pathogens during public health ...
RAPS

Recon: FDA orders new eye risk warnings for Ozempic, Zepbound; FDA launches investigation of Novartis’ Zolgensma after cancer cases

Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is ...