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 ...
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 ...
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 ...
A panel of regulators convened at the 2026 RAPS Convergence to discuss several initiatives underway in Europe to help ...
In Focus: International Novo to pay up to $2.6 billion to China's Hengrui for rights to weight-loss pill (Bloomberg) (Financial Times) EU pharma reform package takes step forward with formal council ...
CHARLOTTE, NC — When submitting a biologics license application (BLA), it is important to engage with the US Food and Drug Administration’s (FDA) Office of Therapeutic Products (OTP) early, make every ...
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