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Panel to Discuss Drug Development for Smallpox Infection

[ Price : $8.95]

Federal Register Notice: FDAs Antiviral Drugs Advisory Committee will meet 12/14-15 to discuss developing drug to treat smallpox i...

Workshop to Discuss Drug Abuse Liability Assessment

[ Price : $8.95]

Federal Register Notice: FDA plans a public workshop 11/10 to discuss the science of abuse liability assessment.

FDA Says AlloStem Product Needs BLA

[ Price : $8.95]

FDA says AlloSource needs to submit a BLA for its AlloStem cell-scaffold product, which is intended to be used as a bone graft.

FDA Proposes User Fees for Device Reviewer Bonuses

[ Price : $8.95]

FDA proposes using user fee money to award retention bonuses to CDRH device reviewers to help improve consistency with device revi...

Pfizer Sues Watson Labs to Block Generic Embeda

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Pfizer sues Watson Laboratories over an ANDA seeking approval to market a generic copy of King Pharmaceuticals' Embeda.

Panel to Discuss Contura PMA for Facial Wrinkles

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Federal Register Notice: FDAs General and Plastic Surgery Devices Panel will meet 12/1 to vote on a Contura, Inc. PMA for Aquamaid...

BioCurex Requests pre-IDE Talks with FDA on RECAF Prostate Test

[ Price : $8.95]

BioCurex submits information and requests a pre-Investigational Device Exemption meeting with FDA to discuss its RECAF test for us...

Venture Capital Survey Cites FDA as Driving Away Investment

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A survey of more than 150 venture capital firms finds them decreasing investments in U.S. biopharmaceutical and medical device com...

FDA Clears New MRI System Made by GE

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FDA clears a GE Healthcare 510(k) for the Discovery MR750w wide bore 3.0T magnetic resonance imaging (MRI) system.

CDRH Releases SOPs for a Network of Experts

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Federal Register Notice: CDRH releases two draft standard operating procedures on networks of experts the Center needs to consult ...