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Injunction Against SD Laser Manufacturer

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A South Dakota federal judge approves a permanent injunction sought by FDA to prevent 2035 Inc. and its president, Robert Lytle, f...

FDA Clinical Hold on Advaxis Trials After Patient Death

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FDA places on clinical hold four Advaxis clinical trials involving axalimogene filolisbac in response to a recent report from the ...

FDA Approves Insightecs Exblate for Uterine Fibroids

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FDA approves Insightecs Exablate system to treat symptomatic uterine fibroids with MRI guidance.

FDA Clears Luminex ARIES HSV System and Assay

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FDA clears a Luminex Corp. 510(k) for the ARIES System and ARIES HSV 1&2 Assay, which is intended for use in detecting herpes simp...

Petition Seeks Contraindications for Anticoagulants

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Self-described whistleblower David Cundiff asks FDA to revoke approval for anticoagulant drugs as stroke prophylaxis for non-valvu...

FDA Corrects Notice on Pediatric Disease Vouchers

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Federal Register Notice: FDA corrects a docket number in a notice on fees for using a rare pediatric disease priority review vouch...

Panel to Discuss Hemorrhoid Classification Codes, Heart Care System

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Federal Register Notice: FDAs Gastroenterology and Urology Devices Panel will meet 11/18-19 to discuss a heart organ care system a...

OCI Probe Leads to Indictment for Product Tampering

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An investigation by FDAs Office of Criminal Investigations leads to an indictment of Nathan Baum of Greenbush, NY, for tampering w...

FDA Guidance on Integrated Summary of Effectiveness

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FDA posts a guidance on the Integrated Summary of Effectiveness, which recommends the content of such sections in NDAs and BLAs.

CBER Head Midthun to Retire at Year-end

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After 22 years of service, CBER director Karen Midthun announces her intention to retire at the end of the year.