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FDA Still Evaluating Left Atrial Occlusion Implants

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FDA continues to evaluate information about the potential for differences in procedural outcomes between women and men undergoing ...

New Theories of False Claims Act Liability

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A lengthy online newsletter written by several Skadden attorneys explores possible new theories of cybersecurity False Claims Act ...

AdvaMed Comments on Electronic Submission Guide

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AdvaMed raises concerns about an FDA draft guidance on De Novo electronic submissions.

Concerns About FDA QMM Program

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The Association for Accessible Medicines raises several issues and concerns with FDAs proposal to develop a quality management mat...

Durbin, Grassley Push Drug Ad Transparency Bill

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Sen. Mike Crapo blocks an attempt by Sens. Dick Durbin and Charles Grassley to get unanimous consent to approve their bipartisan d...

FDA Opens Drug Supply Chain Security Act Portal

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FDA launches a Drug Supply Chain Security Portal as part of the CDER Next Gen Portal.

FDA Denies Apixaban ANDA Petition for Safety

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FDA denies for reasons of safety a 2017 petition seeking approval to submit an ANDA for a generic form of Bristol-Myers Squibbs El...

SCA Pharma Issued 10-Item FDA-483

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FDA posts a 10-item Form FDA-483 related to an inspection last month at SCA Pharmaceuticals Windsor, CT outsourcing facility.

Regenerative Medicine Consensus Standards Guide

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FDA publishes a guidance describing CBERs standards recognition program for regenerative medicine therapies.

Similar Intas CGMP Violations

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FDA warns Intas Pharmaceuticals about repeat CGMP violations at its drug manufacturing facility in Matoda-Sanand, Ahmedabad, India...