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FDA daily

FDA daily for Tuesday, October 13, 2026

In this issue: 8 approvals, 3 device recalls, 17 device decisions and 3 label changes.

Drug and biologic approvals

FDA date:

On Tue, Oct 6 FDA approved 2 new applications (0 brand or biologic, 2 generic) and 6 supplements to existing ones.

Browse drug and biologic approvals in FDA data →

Device recalls

FDA date:

FDA posted 3 device recalls from 2 firms on Tue, Oct 6.

Browse device recalls in FDA data →

Device clearances and approvals

FDA date:

FDA decided 12 510(k)s and 5 PMA decisions on Tue, Sep 29.

Browse device clearances and approvals in FDA data →

Label updates

FDA date:

3 drug labels took effect on Tue, Sep 29. Below: those, and labels carrying a boxed warning.

  • Clopidogrel

    CLOPIDOGREL BISULFATE · Westminster Pharmaceuticals, LLC · ORAL

    Boxed warningHUMAN PRESCRIPTION DRUG
  • Temazepam

    TEMAZEPAM · Preferred Pharmaceuticals Inc. · ORAL

    Boxed warningHUMAN PRESCRIPTION DRUG
Browse label updates in FDA data →

FDA did not answer for Drug shortages, Food and supplement recalls, Drug recalls 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.