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 ...
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 ...
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 ...
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 ...
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 ...
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