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Panel to Discuss Zogenix NDA for Pain

[ Price : $8.95]

Federal Register Notice: FDAs Anesthetic and Analgesic Drug Products Advisory Committee will meet 12/7 to discuss a Zogenix NDA fo...

FDA Panel Backs Novo Nordisk New Insulin

[ Price : $8.95]

FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes to recommend approval of Novo Nordisk's new long-acting insulin d...

Baxter Recalls Buretrol Solution Sets

[ Price : $8.95]

Baxter Healthcare recalls its Buretrol Solution Sets because the devices ball-valve feature may not function as expected.

Blood Panel to Meet

[ Price : $8.95]

Federal Register Notice: FDAs Blood Products Advisory Committee will meet 12/4-5 to discuss labeling of red blood cells and infect...

FDA Intensifies Inspections at Hospira Plants

[ Price : $8.95]

Hospira CEO Michael Ball says FDA recently intensified its inspections of the troubled medical product maker.

AdvaMed Wants UDI Rule to be More Practical, Useful

[ Price : $8.95]

In contrast to company comments, AdvaMed asks FDA to make changes to its proposed unique device identification system to make the ...

FDA Fast Track for Pediatric Crohns Therapy

[ Price : $8.95]

FDA awards Soligenix fast track status for SGX203 (oral beclomethasone 17, 21-dipropionate) for inducing treatment of mild-to-mode...

FDA Clears Cytomedix Angel Platelet Rich Plasma System

[ Price : $8.95]

FDA clears a Cytomedix 510(k) for its Angel Concentrated Platelet Rich Plasma System.

FDA Inspection Cites Thoratec on HeartMate II Design Validation

[ Price : $8.95]

A May FDA inspection of Thoratecs Pleasanton, CA medical device manufacturing facility finds issues with the company design valida...

Highly Multiplexed Microbiological/Medical Devices Guidance

[ Price : $8.95]

FDA publishes a draft guidance on studies for establishing performance characteristics of highly multiplexed microbiological/medic...