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Gottlieb Weighs in on Coronavirus Therapies

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Former FDA commissioner Scott Gottlieb weighs in on hydroxychloroquine for treating coronavirus and what he sees as the better pot...

Info Collection on Dietary Supplement GMPs

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Federal Register notice: FDA sends to OMB an information collection revision entitled Current Good Manufacturing Practice in Manuf...

Dr. Reddys India API Facility Hit with 483

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FDA posts a 3/5 FDA 483 citing a Dr. Reddys Laboratories inspection at a Telangana, India active pharmaceutical ingredient (API) f...

Info Collection on FOIA Identity Certification

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Federal Register notice: FDA sends to OMB an information collection extension for Certification of Identity; Form FDA 3975.

Guide on Improvised Face Masks

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FDA posts a guidance on Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (Covid-19) Public Health ...

BD, BioGX Gets EUA for New Covid Test

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FDA grants Becton, Dickinson and BioGX an emergency use authorization for a new diagnostic test that will enable hospitals to scre...

Info Collection on Special Protocols

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Federal Register notice: FDA submits to OMB an information collection revision for Special Protocol Assessments.

FDA Cites Shilpa India Drug Facility on GMPs

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FDA posts a 15-item FDA 483 issued 2/25 to Shilpa Medicare following an inspection of the firms Telangana, India drug manufacturin...

Device User Fee Meeting to be Webcast

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FDA announces a 5/5 public meeting entitled Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 that will be ava...

FDA Reclassifying Some Hepatitis Tests

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Federal Register notice: FDA proposes to reclassify certain hepatitis C virus antibody assay devices from Class 3 to Class 2 (gene...