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Policies Needed for Advisory Panel Interest Conflicts: Public Citizen

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Public Citizen Health Research Group founder Sidney Wolfe says FDA must immediately improve ethics training for advisory committee...

Results of Large Clinical Trials Often Unpublished

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Researchers writing online in the BMJ say too few large clinical trials are publishing results in peer-reviewed journals or postin...

FDA Accepts Afrezza NDA Resubmission

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FDA accepts for review a MannKind NDA resubmission for Afrezza (insulin human [rDNA origin]) inhalation powder, indicated for impr...

FDA Clears Tria Beauty Age-Defying Laser

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FDA clears a Tria Beauty 510(k) for its over-the-counter Age-Defying Laser and its use to reduce wrinkles.

FDA Orphan Drug Status for Joint Infection Therapy

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FDA has granted Cempra an orphan drug designation for Taksta (CEM-102) for treating prosthetic joint infections.

FDA Wants Lab Data in Systme International Unit Standards

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CDER and CBER consider requiring laboratory data in clinical trials that are measured and reported in Systme International units i...

FDA Working on Mammography Regulation Amendments

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FDA denies a petition seeking enforcement of mammography regulations and says it is developing proposed amendments to the regulati...

FDA Approves Impax/Tolmar Generic Solaraze

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FDA approves an Impax Laboratories and Tolmar ANDA for a generic version of PharmaDerms Solaraze Gel (diclofenac sodium-3%), indic...

Brovana Brochures Have Multiple Violations, OPDP Says

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CDERs Office of Prescription Drug Promotion says patient brochures for Sunovions Brovana make unsubstantiated efficacy claims and ...

FDA Wants to Study Adolescents Reactions to DTC Drug Ads

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FDA solicits comment on a plan to research how adolescents respond to risk and benefit information in DTC drug ads marketed to the...