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FDA Tentatively OKs Impaxs Generic Effexor

[ Price : $8.95]

FDA tentatively approves an Impax Labs ANDA for a generic version of Wyeths Effexor XR.

Pfizer Dumps Inhaled Insulin Exubera

[ Price : $8.95]

Pfizer decides to abandon its inhaled insulin product Exubera after disappointing sales and physician resistance.

FDA Approves Doribax

[ Price : $8.95]

FDA approves J&Js Doribax for treating complicated urinary tract and intra-abdominal infections.

Remote Medication Management System

[ Price : $8.95]

FDA issues a guidance in conjunction with a notice classifying remote medication management systems as Class 2.

Dissolution Calibration Guidance

[ Price : $8.95]

CDER publishes a guidance on using mechanical calibration as an alternate to calibrator tablets in dissolution testing apparatus.

CVM Should Stop Approving Human-use Antibiotics

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Consulting editor John Scharmann reviews CVMs recent approval of florfenicol in the light of growing concern about antibiotic-resi...

GAO Finds Continuing FDA Dissent on TMJ Implants

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A GAO report finds continuing internal CDRH disagreement with FDAs 2001 approval of a device made by TMJ Implants Inc., now fighti...

FDA Clears bioMrieuxs Sepsis Assay

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FDA clears a bioMrieux 510(k) for the Vidas Brahms PCT test for assessing a patients risk for developing severe sepsis.

FDA Proposes Change on Live Vaccine Processing Regs

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Federal Register Proposed rule: FDA proposes to amend the biologics regulations by providing options for live vaccine processing r...

OMB OKs Special Protocol Assessment Info

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Federal Register Notice: The Office of Management and Budget approves a collection of information on a guidance on special protoco...