Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

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 Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Foc ...

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 ...

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 ...

A panel of regulators convened at the 2026 RAPS Convergence to discuss several initiatives underway in Europe to help ...

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 ...

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 ...

Food & Nutrition FDA warns three Northeast food importers about missing supplier verification programs (Food Safety News) Testing finds widespread microplastics, lower heavy metals in baby foods (Food ...