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Bedford Laboratories Expands Leucovorin Recall

[ Price : $8.95]

Bedford expands its recall of liquid leucovorin calcium injection to include all lots within expiry due to the potential for cryst...

Toxicological Research Meeting Planned

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Federal Register Notice: FDA plans a meeting of the Science Advisory Board to the National Center for Toxicological Research 10/23...

Nominations Sought for TSE Committee

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Federal Register Notice: FDA seeks participants in the selection of representatives for the Transmissible Spongiform Encephalopath...

Praise for PMA Filing Guidance

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Industry trade groups and companies praise FDA efforts in its draft guidance on acceptance and filing review of PMA applications.

FDA 'Fast Track for Marburg, Ebola Virus Therapeutics

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FDA grants Sarepta Therapeutics fast track status for developing AVI-7288 and AVI-7537, indicated for treating Marburg virus and E...

CDRH Draft Guidance Urges More Women in Trials

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A new CDRH draft guidance aims to increase women participation in medical device clinical trials and to ensure that data from such...

FDA Approves Excor Pediatric Heart Failure System

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FDA approves a Berlin Heart humanitarian device exemption for the Excor Pediatric System, a device intended to support the weakene...

Product Approval Summaries

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FDA Review posts product approval summaries for the week ending 12/16.

Industry Supports FDA Proposals on Biosimilars User Fees

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Presenters at an FDA-sponsored public meeting to consider a proposed user fee program for biosimilars offer uniform support for th...

FDA Monitoring Reports on Boston Scientific Promus Heart Stent

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FDA says it required a warning about longitudinal stent deformation on the labeling of Boston Scientifics Promus Element heart ste...