Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, we ...

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 ...

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, we ...

The Regulatory Affairs Certification (RAC) is the leading credential for regulatory professionals in the healthcare sector. The two RAC designations are Pharmaceuticals (RAC-Drugs) and Medical Devices ...

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 ...

The International Coalition of Medicines Regulatory Authorities (ICMRA) issued a joint statement encouraging manufacturers and national control laboratories to reduce animal testing throughout the ...

The Council of the European Union has adopted new rules for the pharmaceutical sector, advancing efforts to reform legislation governing the industry. Lawmakers voted 26 to 1 in favor of the reforms.

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 ...

FDA looks for evidence behind the corrective action Many companies recalled product, opened corrective and preventive actions (CAPAs), revised procedures, submitted records, or wrote to FDA more than ...

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 ...