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Panel to Discuss Guillain-Barre, Adult Vaccines

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Federal Register Notice: FDAs Vaccines and Related Biological Products Advisory Committee will meet 11/16 to discuss Guillain-Barr...

FDA Staff Discuss Ventilator Alarms in Journal

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Three CDRH staff members give steps for reducing preventable ventilator alarm errors in a nursing journal.

FDA Approves Jubilant's Generic Protonix

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FDA approves a Jubilant Life Sciences ANDA for a generic copy of Wyeths Protonix.

Agreement Reached on Generic Drug User Fee Goals

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Participants in negotiations for a generic drug user fee program reach agreement on program goals and funding.

Comments Sought on Petition Commissioner Regulations

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Federal Register Notice: FDA seeks comments on the reporting requirements in agency administrative procedures when a person aims t...

Panel Meeting Slated to Discuss Prostate Cancer Assay Postponed

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Federal Register Notice: FDA postpones a 10/14 meeting of the Immunology Devices Panel.

FDA Orders Class Warning for TNF-Alpha Blockers

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FDA orders a class boxed warning for all marketed tumor necrosis factor-alpha blockers to include information about a risk for inf...

Senator Urges Uniform Drug Pedigree to Prevent Shortages

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U.S. Senator Michael Bennet (D-CO) urges FDA to implement a uniform pedigree standard that would allow the FDA to efficiently moni...

Senate FDA Appropriations Bill Seeks $50 Million Boost

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The Senate Appropriations Committee approves an FDA FY 2012 proposed budget that includes about a $50 million (2%) increase over F...

NORD Asks for Orphan Drug Review Policy

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The National Organization for Rare Disorders petitions FDA for a policy statement on orphan drug review.