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Reinspect Warned Compounding Pharmacies: Public Citizen

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Public Citizen calls on FDA to immediately reinspect all compounding pharmacies that received Warning Letters in the past to ensur...

Guidance on Testing Preclinical Cell, Tissue, Gene Products

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CBER issues a draft guidance with recommendations for information needed to support clinical trials for investigational cell, tiss...

FDA Panel Backs J&J Tuberculosis Therapy

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FDAs Anti-Infective Drugs Advisory Committee unanimously votes to support efficacy findings with Janssen Research & Developments b...

CDRH Cover-up on Device Classification Form Changes: Petitioner

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CDRH comes under fire after quietly revising its Classification Questionnaire (Form FDA 3429) based on a citizen petition that que...

Dara BioSciences Seeks Orphan Status for Chemo Pain Drug

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Dara BioSciences files an Orphan Drug Application for KRN5500, a compound in development to treat a painful form of chronic chemot...

FDA Approves Mylans Generic Detrol

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FDA approves a Mylan ANDA for tolterodine tartrate tablets (1mg and 2mg), a generic version of Pharmacia and Upjohns Detrol.

Comments Sought on Biologics Constituent Materials

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Federal Register Notice: FDA seeks comments on a proposed collection of information on the use of constituent material in biologic...

Panel to Discuss Shortwave Diathermy Device Reclassification

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Federal Register Notice: FDAs Orthopedic and Rehabilitation will meet 4/5/13 to discuss the possible reclassification to Class 3 o...

Ranbaxy Stops Generic Lipitor Pending Recall Probe

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FDA says Ranbaxy has stopped manufacturing generic Lipitor (atorvastatin) until it has resolved an earlier reported recall problem...

FDA Lists October Drug Safety Alerts

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FDA tells consumers about drug safety alerts issued in October.