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Petition Asks Articaine Product Terminal Sterilization

[ Price : $8.95]

A citizen petition asks FDA not to approve any articaine-containing dental anesthetics manufactured with aseptic processing rather...

Investors Should Have Found Vioxx Problems: Merck

[ Price : $8.95]

Attorneys for Merck say that investors shouldnt be allowed to sue the company for fraud over Vioxx because they didnt work hard en...

FDA Publishing Adapalene Bioequivalence Guidances

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FDA says it is publishing four guidances for individual adapalene products recommending comparative clinical trials for any ANDAs.

FDA OKs Alpharma sANADA for Bacterial Diseases

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Federal Register Final rule: FDA approves an Alpharma ANADA for using generic chlortetracycline soluble powder to make medicated d...

Correction on Pediatric Panel Notice

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Federal Register Notice: FDA corrects a docket number in an 11/2 notice on a Pediatric Advisory Committee meeting.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Centra Support Building, King Systems, TLC Eye Care-Lansing, and Wellspring Inte...

FDA Clears Masimo Respiration Rate Monitor

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FDA clears a Masimo 510(k) for the Masimo Rainbow SET Acoustic Monitoring system for monitoring continuous respiration rate in pos...

FDA Raises Numerous Issues on Ampligen NDA

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FDA calls for an additional clinical trial to support Hemispherx Biopharmas Ampligen NDA.

Teva Files BLA for Neupogen Biosimilar

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Teva submits a BLA for XM02, a granulocyte colony-stimulating factor (G-CSF) indicated for reducing the duration of severe neutrop...

FDA Makes Product-Specific BE Recommendations

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Federal Register Notice: FDA releases additional draft and revised draft product-specific bioequivalence recommendation.