Regulatory Affairs Professionals Society

QMSR: FDA, industry experts discuss transition, inspection anxiety

Despite some early jitters, the medtech industry is coming around to the Quality Management System Regulation (QMSR), ...
Regulatory Affairs Professionals Society

Recon: German Merck acquires Silence Therapeutics for $1.3B; China's Hansoh Pharma strikes $15B drug deal with Roche

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 ...
Regulatory Affairs Professionals Society

This Week at FDA: HHS staff assessments raise concerns, former FDA chiefs criticize DOGE, and more

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

Study: Patient, consumer reps at FDA adcomms increasingly hold ties to pharma-backed advocacy groups

At some advisory committee meetings, more than half of patient and consumer representatives who attended had connections to ...
Regulatory Affairs Professionals Society

FDA launches rare disease framework initiative

A new initiative from the US Food and Drug Administration (FDA) aims to develop “an optimized, fit-for-purpose” framework to ...
RAPS

Ontario Chapter In Person Event: SGS Canada and RAPS Medical Device Symposium

SGS is excited to bring to the GTA a comprehensive full-day symposium focused on the medical device industry. In partnership with the RAPS Ontario Chapter, the leading association for regulatory ...
Regulatory Affairs Professionals SocietyOpinion

Experts favor a new regulatory framework for clinical AI models

Congress should enact a specific regulatory framework for artificial intelligence (AI) models developed and used in academic ...
RAPS

FDA warning letters raise concerns about CGMP, GLP violations

The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers for failing to meet current good manufacturing practices (CGMP) requirements, and to a research ...
RAPS

Recon: ImmunityBio’s Anktiva clears FDA expansion in bladder cancer; “Gross contamination” found at Chinese site manufacturing GLP-1 components

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 ...
RAPS

MHRA announces strategy to streamline regulation in the AI era

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has adopted a multi-year strategy aimed at ensuring continued patient-centered regulation in the era of emerging artificial ...