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Pros and Cons of Disseminating Off-label Info Debated

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Former FDA chief counsel Dan Troy and assistant U.S. attorney Michael Loucks face off in discussion of policies and the law govern...

Cross Vet. sNADA for Bovine Respiratory Disease OK'd

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Federal Register Final rule: FDA approves a Cross Vetpharm Group supplemental NADA for a 100 mg/mL strength erythromycin injectabl...

Science Recommendations Will Require Vast Sums

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Consulting editor John Scharmann reviews the Science Board report on FDA and finds its recommendations will require vast amounts o...

Cobalt Wants Precose Bioequivalency Shown

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Cobalt Laboratories asks FDA to require in vivo bioequivalence studies for any ANDAs for a generic form of Bayers Precose.

Vidacare Gains Clearance for Biopsy System

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Vidacare receives 510(k) clearance for the OnControl Bone Marrow Biopsy System.

FDA Panel Backs Huntingtons Disease Drug

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An FDA advisory committee unanimously votes to recommend approval of Prestwick Pharmaceuticals tetrabenazine, indicated for treati...

Orphan Drug Status for Celldexs Brain Cancer Drug

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FDA grants orphan drug status to Celldex Therapeutics CDX-110, indicated for treating EGFRvIII-expressing brain cancer.

Advisors Look at Atrial Fibrillation Products

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FDAs Cardio-Renal Advisory Committee will consider recommendations for two drugs to treat atrial fibrillation.

Amgen, FDA Updating ESA Labels

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FDA and Amgen discuss safety labeling changes for ESAs based on new study results.

Europeans Say Our DTC Regulation Has Failed

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Four European health groups urge strict control of DTC advertising there, saying U.S. regulation has failed.