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Comments Sought on Single-Use Device Labeling

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

Somatuline Depot Review Period Set

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Federal Register Notice: FDA determines the regulatory review period for patent extension for Tercicas Somatuline Depot.

Guidance Sought on Oritavancin NDA

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

Thermogenesis Recalls AXP Processing Bagset

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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...

Sinus Science Web Site False, Misleading

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FDA warns Aerosol Science Laboratories that it is marketing an unapproved device and making unsubstantiated efficacy and superiori...

C-Path Institute Gets $9 Million for Critical Path

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Critical Path Institute (C-Path) wins a $9 million grant from Science Foundation Arizona to help it advance a streamlined drug dev...

Preliminary Injunction Standard Clarified

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The U.S. Supreme Court says plaintiffs seeking a preliminary injunction must show they will suffer irreparable harm without it.