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Panel to Vote on Genzymes Knee Treatment

[ Price : $8.95]

Federal Register Notice: FDAs Orthopedic and Rehabilitation Devices Panel will vote on a Genzyme PMA for Synvisc-One.

Error Corrected in Biologics Regs

[ Price : $8.95]

Federal Register Final rule: FDA amends the biologics regulations to correct an error.

Guidance Sought on Oritavancin NDA

[ Price : $8.95]

CDER seeks advisory committee comment on the safety and effectiveness of Targanta Therapeutics Oritavancin for treating complicate...

Thermogenesis Recalls AXP Processing Bagset

[ Price : $8.95]

CBER says Thermogenesis is recalling two lots of its AXP Processing Bagset due to potential contamination.

CDRH Staff Charge High-Level Misconduct

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A purportedly large group of CDRH physicians and scientists say Center managers have ignored sound science and forced approval of ...

Committee to Consider Telavancin Pregnancy Risks

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Advisors are asked to consider risks that Theravances telavancin presents to pregnant women.

Mylan Challenges Takeda Actos Generic Petition

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Mylan says FDA should not approve Takedas citizen petition seeking to require all applicants for generic Actos to label their prod...

FDA Tentatively OKs Mylans Generic Effexor

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FDA tentatively approves a Mylan ANDA for a generic copy of Wyeths Effexor XR.

FDA Posts Lifecycle Process Validation Guide

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FDA posts a long-awaited drug manufacturing process validation draft guidance entitled Process Validation: General Principles and ...

Comments Sought on Single-Use Device Labeling

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Federal Register Notice: FDA seeks comments on single-use device labeling.