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2 Stakeholders Responses on Orange Book Q&A

[ Price : $8.95]

Two drug company stakeholders respond to an FDA draft guidance on Orange Book questions and answers.

Reasons HHS Decision on Lab Tests Was Good: Attorney

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Attorney Jeffrey Shapiro discusses reasons why HHS made the right decision in ordering FDA to abstain from the premarket review of...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes Acella Pharmaceuticals, Mylan and Revival Products.

Combination Product Review Practices Work Well: Report

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An assessment finds that combination product review practices are generally efficient and effective and need only minor adjustment...

Indivior Exec Pleads Guilty in Suboxone Film Case

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The Justice Department says the former Indivior global medical director has pleaded guilty to a single misdemeanor charge of intro...

Nitrosamine Control Guidance Out

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FDA issues a guidance to help manufacturers prevent unacceptable levels of nitrosamines in all chemically synthesized drugs.

Hahn Should Tell Truth or Resign: Topol

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Scripps Research Translational Institute director Eric Topol writes an open letter to FDA commissioner Stephen Hahn asking him to ...

Dont Let Orange Book Block Competition: 23 AGs

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Twenty-three attorneys general ask FDA not to allow branded drug companies to list device and component patents in the Orange Book...

Regulatory Review Period for Lumoxiti

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Innate Pharmas Lumoxiti.

Info Collection on Biologic Adverse Experience Reporting

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Federal Register notice: FDA seeks comments on an information collection extension for Adverse Experience Reporting For Licensed B...