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Elite Laboratories PADE Reporting Violations

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FDAs New Jersey District Office warns Elite Laboratories about its failure to implement Postmarketing Adverse Drug Experience repo...

FDA, EMA Rare Diseases Cluster

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FDA and the European Medicines Agency agree on operating procedures for a new joint cluster on rare diseases.

Notice on Biomarkers Listing Corrected

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Federal Register Notice: FDA corrects a 9/19 notice entitled "A List of Biomarkers Used as Outcomes in Development of FDA-Approved...

Janssen Files Imbruvica sNDA for Lymphoma

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Janssen Research & Development files a supplemental NDA for Imbruvica (ibrutinib) for treating patients with marginal zone lymphom...

Public Meeting for Generic Drug User Fee Reauthorization

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Federal Register Notice: FDA announces a public meeting to discuss proposed recommendations for reauthorizing the Generic Drug Use...

FDA Clears Roche 510(k) for Syphilis Assay

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FDA clears a Roche 510(k) for the Roche Syphilis treponemal antibody test, a fully automated assay for detecting antibodies to Tre...

Sherman Moves Into Califfs Former Position

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FDA promotes associate deputy commissioner for medical products and tobacco Rachel Sherman to deputy commissioner for medical prod...

FDA Probe Leads to Charge Against Drug Importer

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After an FDA Office of Criminal Investigations probe, federal prosecutors charge a Hoover, AL man with receiving and reselling mis...

Sen. Cotton Introduces Generic Drug Priority Bill

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U.S. senator Tom Cotton (R-AK) introduces the Safely Advancing Valuable and Inexpensive New Generic Solutions Act, a bill that wou...

FDA Approves Janssens Stelara for Crohns

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FDA approves a Janssen Biotech BLA for Stelara (ustekinumab) for treating moderately to severely active Crohns disease in adults (...