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Comments on ICH Pediatric Extrapolation Guidance

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Two drug stakeholder associations raise questions and suggest changes to an International Council for Harmonization draft guidance...

Revised Expanded Access Q&A Guidance

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FDA issues an updated question-and-answer draft guidance on expanded access to investigational drugs for treatment use.

Dont Approve Some Tc-99m NDAs: Petition

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A citizen petition asks FDA not to approve any Technetium-99m product produced through neutron capture in a conventional generator...

CGMP Violations at Lupin Limited

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FDA warns Indias Lupin Limited about CGMP deviations in the production of active pharmaceutical ingredients.

Use of Expedited Drug Review Programs Increasing

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FDA researchers say industry use of the accelerated approval, breakthrough therapy, fast track, and priority review programs has i...

FDA Defers Action on Amicus BLA

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FDA says it is deferring action on an Amicus BLA for cipaglucosidase alfa as part of a treatment for Pompe disease until the agenc...

Pfizer Plans BLA for RSV Vaccine

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Pfizer plans a year-end BLA for its investigational bivalent respiratory syncytial virus vaccine after stopping enrollment in a Ph...

CDRH Testing Communications Info Collection

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Federal Register notice: FDA seeks comments on an information collection entitled Testing Communications by FDAs Center for Device...

Measuring Growth/Pubertal Development Guide

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Federal Register notice: FDA makes available a draft guidance entitled Measuring Growth and Evaluating Pubertal Development in Ped...

Guide on Cell/Tissue-based Products

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Federal Register notice: FDA makes available a final guidance entitled Regulation of Human Cells, Tissues, and Cellular and Tissue...