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FDA/CDC Dismiss Signal with Pfizer Bivalent Vaccine

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FDA and CDC dismiss a recent potential safety signal suggesting Pfizers bivalent Covid-19 vaccine may cause ischemic stroke in peo...

Guide on Drug Dosage and Administration Labeling

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Federal Register notice: FDA posts a draft guidance entitled Dosage and Administration Section of Labeling for Human Prescription ...

Digital Sleep Disturbance Devices are Class 2

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Federal Register notice: FDA classifies digital therapy devices used to reduce sleep disturbance for psychiatric conditions into C...

5 Observations in Alembic FDA Inspection

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Indias BQ Prime financial news platform discloses five observations from an FDA inspection at an Alembic Pharmaceuticals non-steri...

Stop Trying to Prevent Covid in Healthy People: Offit

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FDA vaccines advisory committee member Paul Offit says the U.S. should stop trying to prevent symptomatic Covid infections in heal...

Dosage and Administration Label Section Guidance

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FDA publishes a guidance to help applicants prepare the Dosage and Administration section of labeling for prescription drug and bi...

Minor Updates to 2 Covid Test Guidances

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FDA announces updates to two Covid-19 testing guidances.

Qualigen Therapeutics Gains Orphan Drug Designation

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FDA grants Qualigen Therapeutics an orphan drug designation for QN-302 and its use in treating pancreatic cancer.

Oramed Shelves Diabetes Drug After Phase 3 Miss

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Oramed Pharmaceuticals discontinues clinical development of its Type 2 diabetes drug ORMD-0801 after a Phase 3 clinical trial miss...

Photobiomodulation Device 510(k) Submission Guide

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Federal Register notice: FDA releases a draft guidance entitled Photobiomodulation (PBM) Devices Premarket Notification [510(k)] ...