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, ...
Over the last 15 years, there has been an uptick in the number of patents associated with small-molecule drugs approved by the US Food and Drug Administration (FDA), with a majority of the increase ...
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 ...
Food & Nutrition American Academy of Pediatrics calls for nationwide ban of raw milk (Food Safety News) FDA begins onsite inspections in E. coli, Listeria outbreak investigations (Food Safety News) ...
Learn how AI-enabled CER workflows can help regulatory teams improve efficiency, traceability, and MDR compliance while strengthening Notified Body readiness and preserving expert oversight. Most ...
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 ...
All stages of the drug development lifecycle require the proper adherence to regulatory chemistry, manufacturing and control (CMC) requirements. Join this two-day workshop for an overview of CMC ...
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 ...
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