FDA daily

FDA daily for Thursday, May 15, 2025

In this issue: 16 approvals, 3 device recalls and 18 device decisions.

Drug and biologic approvals

FDA date:

On Thu, May 8 FDA approved 1 new application (1 brand or biologic, 0 generic) and 15 supplements to existing ones.

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Device recalls

FDA date:

FDA posted 3 device recalls from 3 firms on Thu, May 8.

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Device clearances and approvals

FDA date:

FDA decided 12 510(k)s and 6 PMA decisions on Thu, May 1.

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FDA did not answer for Drug recalls, Drug shortages, Food and supplement recalls, Labels while this issue was written; those sections will fill in on a later visit.

How the FDA daily is written

Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug and device recalls, and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Complete response letters appear the day after FDA publishes a batch.

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.