The US Food and Drug Administration (FDA) recently released a transparency roadmap outlining its achievements in FY 2026 and its priorities for FY 2027. Two key priorities for the future include a ...
A panel of regulators convened at the 2026 RAPS Convergence to discuss several initiatives underway in Europe to help ...
The Medicines and Healthcare products Regulatory Agency (MHRA) says the UK government has adopted a list of recommendations on the use of artificial intelligence (AI) in medical devices developed by ...
Food & Nutrition FDA found Cyclospora during Taylor Farms inspection in Mexico (New York Times) (AP News) EU-funded project to develop novel technologies for continuous microbial monitoring in poultry ...
Finalizing guidance on artificial intelligence-enabled devices throughout their product lifecycle and on pre-determined change control plans (PCCPs) tops the to-do list for the US Food and Drug ...
Australia’s Therapeutic Goods Administration (TGA) has adopted two new medicine labeling standards, starting a five-year countdown to mandatory compliance with the updated requirements. The old ...
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 ...
The US Food and Drug Administration (FDA) has issued notices inviting subject-matter experts and consumer representatives to volunteer for its advisory committees. The move comes after the role of FDA ...
The World Health Organization (WHO) has issued an updated draft guideline to assist manufacturers establish an effective quality risk management (QRM) system and to help regulators in planning their ...
The US Department of Health and Human Services on Wednesday announced a program and funding opportunity through the Advanced Research Projects Agency for Health (ARPA-H) called the ...