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No Increased Reporting From FDA Drug Alerts: Study

[ Price : $8.95]

An AdverseEvents study shows that FDA drug alerts and warnings dont lead to increased adverse events reports on those drugs.

System of Record MAPP Issued

[ Price : $8.95]

CDER issues a MAPP documenting its System of Record and Office of Business Informatics responsibilities.

FDA Draft Guidance on Lab-Developed Test Framework

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FDA posts a draft guidance on its Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) that describes a risk-ba...

Collection of Info on Drug Communications Sent to OMB

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Federal Register Notice: FDA submits a proposed collection information on data to support drug product communications to the Offic...

CGMP Problems Seen in Valeant Inspection

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FDAs New Jersey District Office warns Valeant Pharmaceuticals about Quality System Regulation violations in its production of Scul...

Social Media Guidance Problematic: Hale Advisors

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Hale Advisors principal Zoe Dunn writes that FDAs Guidance on Social Media Platforms with Character Space Limitations undermines p...

New Models Needed to Shore Up Declining R&D, Researcher Says

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Washington Universitys (St. Louis) new associate vice chancellor and director of its new Center for Research Innovation in Busines...

Glaxo Reports Positive Results from Melanoma Drug Trial

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GlaxoSmithKline reports positive results from a planned analysis of its Phase 3 BREAK-3 study involving Tafinlar (dabrafenib) in 2...

FDA Inspected Fewer Device Firms Last Year

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An FDA medical device inspection report finds that the agency conducted 3% fewer medical device quality system surveillance inspec...

FDA Approves Alimera Sciences NDA for Illuvien

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FDA approves an Alimera Sciences NDA for Iluvien for treating diabetic macular edema in patients who have been previously treated ...