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Dr. Reddys Rituxan Biosimilar BLA Accepted

[ Price : $8.95]

FDA accepts for review a Dr. Reddys Laboratories BLA for its proposed biosimilar rituximab (Genentechs Rituxan) candidate.

CGMP, Other Issues at NeilMed Pharmaceuticals

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FDA warns Santa Rosa, CA-based NeilMed Pharmaceuticals about CGMP and other issues in its production of finished drugs.

Disclose Drug, Supplement Animal Ingredients: Petition

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VeganMed asks FDA to require drug and dietary supplement manufacturers to disclose in product labeling any animal-derived ingredie...

Boston Scientific Brain Stimulation Software OKd

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FDA approves Boston Scientifics Vercis Neural Navigator 5 Software, which is used as part of the Vercise Genus Deep Brain Stimulat...

FDA Warns 2 Firms on Human Cells/Tissues

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FDA warns New Hope Center for Reproductive Medicine and Regenerative Labs about violations involving human cells, tissue, and cell...

Most Common 2022 BIMO Violations

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Three Goodwin attorneys analyze the results of BIMO inspections in 2022 and the beginning of 2023, listing most common violations....

Consumer Groups Sought for Advisory Panels

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Federal Register notice: FDA asks that consumer organizations notify the agency if they are interested in participating in selecti...

Guide on Metabolism Inborn Errors

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Federal Register notice: FDA makes available a revised draft guidance entitled Inborn Errors of Metabolism That Use Dietary Manage...

BeiGene sNDA for Brukinsa in Lymphoma

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FDA accepts a BeiGene supplemental NDA for Brukinsa (zanubrutinib) in combination with obinutuzumab for treating adult patients wi...

FDA Wants More PSA Applicants

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CDER Office of Generic Drugs associate director of stakeholder and global engagement Sarah Ibrahim uses an agency podcast to urge ...