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Psychopharmacologic Drugs Panel Renewal

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Federal Register notice: FDA renews its Psychopharmacologic Drugs Advisory Committee for an additional two years beyond the charte...

FDA Explains New LabelComp Tool

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FDA says its new LabelComp artificial intelligence tool automates the identification of adverse event changes in drug labeling upd...

FDA OKs Expanded Jemperli Indication

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FDA approves an sBLA expanding the endometrial cancer indication for GlaxoSmithKlines Jemperli.

Abbott Device Correction on FreeStyle Libre 3

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Abbott issues a medical device correction for a small number of FreeStyle Libre 3 sensors because they may provide incorrect high ...

Novartis Sues FDA to Reverse Generic Entresto OK

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Novartis files a lawsuit against FDA that seeks to reverse the agencys recent approval of MSN Laboratories generic version of Nova...

Telix Pharma Hit with Refuse-to-File on BLA

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FDA sends Telix Pharmaceuticals a refuse-to-file letter on its BLA for TLX250-CDx (89Zr-DFO-girentuximab), an investigational imag...

Man Indicted for Selling Counterfeit Cancer Drugs

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The Justice Department says a resident of India has been indicted on federal charges of trafficking in fake cancer drugs sold in t...

New Quantitative Medicine CoE Resources

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The CDER Quantitative Medicine Center of Excellence posts four new resources.

Biosimilar User Fee Rates For FY 2025

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Federal Register notice: FDA set biosimilar user fee rates for fiscal year 2025.

OTC Monograph FY 2025 User Fee Rates

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Federal Register notice: FDA posts the over-the-counter monograph order request fee rates for fiscal year 2025.