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Comments Sought on Patient-Focused Drug Development

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Federal Register Notice: FDA seeks comments on its patient-focused drug development initiative.

OMB OKs Info General Administrative Procedures

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on citizen petitions, petit...

Lupron Depot Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Lupron Depot Injectable 3.75 mg/vial was not withdrawn from sale for reasons of safet...

Guidance on Drug Product Tracing/Distributor Licensing

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Federal Register Notice: FDA releases a draft guidance on the effect of the FD&C Act Section 585 on drug product tracing and whole...

Committee to Discuss Soliris REMS

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Federal Register Notice: FDAs Drug Safety and Risk Management Advisory Committee will meet 11/18 to discuss.

Regen Bio Files IND for dCellVax in Breast Cancer

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Regen BioPharma files an IND with FDA to begin a clinical trial of dCellVax in patients with metastatic breast cancer.

DNAtrix Gets Orphan Drug for Malignant Glioma

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FDA grants orphan drug status to DNAtrix for DNX-2401 for treating malignant glioma.

FDA Approves Salix Pharmas Ulcerative Colitis Drug

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FDA approves Salix Pharmaceuticals Uceris (budesonide) rectal foam, indicated for inducing remission in patients with active mild-...

FDA Co-hosting Cybersecurity Meeting

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CDRHs Suzanne Schwartz outlines several steps FDA is taking to increase cybersecurity for medical devices.

Genentech Files sBLA for Lucentis

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FDA accepts for priority review a Genentech supplemental BLA for Lucentis (ranibizumab injection) for treating diabetic retinopath...