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Guidance on Eosinophilic Esophagitis Drug Development

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Federal Register notice: FDA makes available a final guidance entitled Eosinophilic Esophagitis: Developing Drugs for Treatment.

FDA Misinterpreted Law in Goprelto Case, Court Says

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The DC federal court says FDA misinterpreted the FFDCA when it approved Lannetts Numbrino during the new chemical entity exclusivi...

Azar Overruled Hahn on Covid Test Jurisdiction: Politico

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Politico reports exclusively that HHS secretary Alex Azar ordered FDA to stop evaluating laboratory-developed tests over the objec...

Public Workshop on Drug Integrated Assessments

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FDA announces a 10/30 virtual public workshop on New Drugs Regulatory Program Modernization: Implementation of the Integrated Asse...

Software Pre-Cert Program Far from Operational: Report

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SheppardMullin attorneys say FDA seems to be years away from implementing its pilot software pre-certification program.

Class 1 Recall on Alaris Pump Syringe/PCA Modules

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FDA classifies as Class 1 a recall involving a Becton Dickinson CareFusion recall of its Alaris Syringe and Alaris PCA Modules due...

Trust Down for FDA, Drug Companies: Poll

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Axios/Ipsos poll respondents say they have little faith in FDA or the drug industry to be looking out for the publics interests.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Kalchem International, Mayons Pharmaceuticals and Silkprousa.

False, Misleading Claims in Sprout Addyi Radio Ad: OPDP

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FDA warns Sprout Pharmaceuticals about a violative radio ad for Addyi, indicated for women with low sexual desire.

CGMP Issues at Kalchem

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FDA warns Kalchem International about new and repeated CGMP violations and deviations in its production of finished drugs and APIs...