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Petition Seeks OTC Switch for Oral Contraceptives

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Attorney and former FDA director of medical device compliance Larry R. Pilot petitions the agency asking that it begin the adminis...

Dont Let 510(k) Guidance Become Back Door: MDMA

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MDMA says FDA should not use a draft guidance on 510(k) substantial equivalence decisions to reassess device classifications of pr...

Drug Companies Sharing Trial Data with Researchers

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Rutgers Biomedical and Health Sciences chancellor Brian Strom says an independent advisory committee he chairs encourages drug com...

FDA Approves Arbor NDA for Sotylize

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FDA approves an Arbor Pharmaceuticals NDA for its Sotylize (sotalol hydrochloride) oral solution, indicated for treating documente...

FDA Group Sets Base for Breast Cancer Master Protocol

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An FDA workshop lays the groundwork for a proposed master protocol that the agency is spearheading to advance an international gen...

Homeland Security Probing Device Cyber Flaws

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Reuters reports that the Department of Homeland Security is looking at two dozen medical devices that could be susceptible to cybe...

Diagnostics for Tuberculosis into Class 2

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Federal Register Final Order: FDA classifies nucleic acid-based in vitro diagnostic devices for MTB-complex into Class 2.

Withdraw Distribution of Scientific Info Guide: Public Citizen

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Public Citizen says FDA should withdraw its 6/11 draft guidance on distributing scientific and medical publications because it wou...

FDA Accepts Alkermes NDA for Schizophrenia Injectable

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FDA accepts for filing an Alkermes NDA for aripiprazole lauroxil, an investigational, once-monthly injectable atypical antipsychot...

Guidance on Delaying a Drug Inspection

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Federal Register Notice: FDA is making available a guidance: Circumstances that Constitute Delaying, Denying, Limiting, or Refusin...