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Problem with Roche HIV-1 Monitor Test

[ Price : $8.95]

CBER says Roche Diagnostics has confirmed a problem with the quantitation standard copy number in an HIV-1 monitor test.

No Inventory of Falsodex Injection Remains

[ Price : $8.95]

CDER says that AstraZeneca has no remaining inventory of its discontinued Falsodex Injection.

Comments Sought on ANADAs

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on paperwork associated with ANADAs submitted to CVM.

FDA Issues Emergency Use OK for Flu Drug

[ Price : $8.95]

Federal Register Notice: FDA issues an Emergency Use Authorization for peramivir 200 mg/20 mL (10mg/mL) single use vial for IV adm...

FDA OKs Covidiens Generic Actiq

[ Price : $8.95]

FDA approves a Covidien ANDA for a generic copy of Anesta Corp.s Actiq (oral transmucosal fentanyl citrate), indicated for treatin...

Panel to Vote on Implantable Hearing System

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Federal Register Notice: FDAs Ear, Nose, and Throat Devices Panel will meet 12/18 to vote on an Envoy Medical PMA for the Esteem T...

Panel to Discuss Trials on Prostate Cancer Treatments

[ Price : $8.95]

Federal Register Notice: FDAs Gastroenterology and Uroloy Devices Panel will meet 12/11 to discuss clinical investigations intende...

Neurological Devices Panel Meeting Postponed

[ Price : $8.95]

Federal Register Notice: FDA postpones the 11/20 meeting of Neurological Devices Panel due to a scheduling conflict.

FDA Changes Agenda of Pediatric Panel

[ Price : $8.95]

Federal Register Notice: FDA amends the Agenda portion of the notice of a meeting of the Pediatric Advisory Committee scheduled fo...