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Attorney Blasts CDRH for 8,000-day Petition Delays

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Attorney and data scientist Bradley Thompson blasts CDRH for its lengthy delays of up to 8,000 days in answering an average of 13 ...

User Fee Courier Delivery Address Change

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Federal Register notice: FDA provides notice that the courier address used for user fee payments has changed effective 10/6.

BD Vacutainers EUA Revoked

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Federal Register notice: FDA announces that it revoked the Emergency Use Authorization issued to Becton, Dickinson for the BD Vacu...

Ultram Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Janssen Pharmaceuticals Ultram (tramadol hydrochloride) tablets, 50 mg, was not withd...

Moderna Phase 3 Trial for Flu/Covid Vaccine

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Moderna says it will start a Phase 3 trial of its investigational mRNA-1083 combination flu/Covid vaccine later this year.

Proposed Rule on Lab-developed Tests

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Federal Register notice: FDA proposes to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devic...

Signature Biologics Illegally Marketing Cord Product

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FDA warns Irving, TX-based Signature Biologics that it is illegally marketing its human umbilical cord product that is manufacture...

Repeat CGMP Deviations at Fresenius Unit

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FDA warns Fresenius Kabi about CGMP deviations in its Fenwal International unit in Maricao, Puerto Rico.

KVK-Tech Recalls 1 Betaxolol Lot

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KVK-Tech recalls one lot of betaxolol tablets as a precautionary measure after a single oxycodone HCl tablet was found on the pack...

Oncology Panel to Discuss Accelerated Approvals

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Federal Register notice: FDA announces an 11/16 Oncologic Drugs Advisory Committee meeting to hear an update on the agencys accele...