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30 Oct 2026

This Week at FDA: New ConOps for drug inspections, AI policy proposal, and more

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, FDA announced that its drug center and inspections office have agreed to a new concept of operations (ConOps) for coordinating inspections and other compliance activities, a senator released draft legislation that would give FDA new authorities for overseeing artificial intelligence (AI), and the agency has removed a boxed warning from the labels of estradiol patches.

This Week at FDA
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27 Oct 2026

Experts offer insights on de novo requests, MDUFA VI changes

BOSTON – An expert and officials from the US Food and Drug Administration (FDA) offered tips for de novo classification requests and reviewed some of the changes related to de novos being proposed under the Medical Device User Fee Amendments (MDUFA VI) program at The MedTech Conference last week.

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Why FDA finds Form 483 responses inadequate

Most companies treat the Form 483 response as the chance to close the loop after an FDA inspection. In many warning letters, FDA reaches a different conclusion: the company responded, FDA reviewed the response, and the agency still found the answer incomplete.

 

 

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30 Oct 2026

This Week at FDA: New ConOps for drug inspections, AI policy proposal, and more

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, FDA announced that its drug center and inspections office have agreed to a new concept of operations (ConOps) for coordinating inspections and other compliance activities, a senator released draft legislation that would give FDA new authorities for overseeing artificial intelligence (AI), and the agency has removed a boxed warning from the labels of estradiol patches.

This Week at FDA
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