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House to Vote on Cures Act This Week; Senate Vote Later

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The U.S. House of Representatives schedules an 11/30 floor vote on a revised 21st Century Cures bill that includes $6.3 billion in...

FDA Partially Approves Teva Petition on Generic Amrix

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FDA partially approves a Teva petition that sought tighter bioequivalence on generic copies of its skeletal muscle relaxant Amrix ...

Draft Guide on Submitting Quality Metrics Data

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FDA makes available a revised draft guidance for industry entitled Submission of Quality Metrics Data.

FDA Clears Toshiba CT Scan Reconstruction Solution

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FDA clears a Toshiba Medical 510(k) for the Forward Projected Model-based Iterative Reconstruction Solution that is intended to im...

Comment Period Extended on Antimicrobial Drug Use in Animals

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Federal Register Notice: FDA extends the comment period on a 9/14 notice on the establishment of appropriately targeted durations ...

Pharmaceutical Science Panel to Discuss Model-informed Development

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Federal Register Notice: FDA announces a 3/15/2017 Pharmaceutical Science and Clinical Pharmacology Advisory Committee that will d...

Public Citizen, Others Hit FDA on Intellectual Bias Exclusions

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Public Citizen and seven other consumer and government watchdog groups tell FDA that its draft guidance on Procedures for Evaluati...

OMB Approves Information Collection on 505(b)(2) Applications

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Federal Register Notice: FDA announces that OMB has approved an information collection on Abbreviated New Drug Applications and 50...

Comments Sought on Expedited Programs Guidance Extension

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Federal Register Notice: FDA asks for comments on an information collection extension on its guidance for Expedited Programs for S...

Comments Sought on New DTC Study of Superimposed Text

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Federal Register Notice: FDA seeks comments on a new direct-to-consumer study proposal submitted to OMB for approval on Superimpos...