Ongoing Clinical Oncology Projects

Image  The OCE supports clinical projects to improve oncology product development for the benefit of people with cancer. Jump to: Patient-Focused Drug Development ProgramThe OCE Patient-Focused Drug Development (PFDD) Program continued its mission of incorporating...

DG Gel Cards

STN#:  125445,125449, 125450, 125451, 125452, 125453, 125454, 125455, 125456, 125457Proper Name: Blood Grouping Reagent Combination KitTradename: DG Gel CardManufacturer: Diagnostic Grifols, S. A.Indication:DG Gel 8 AB (x4) card is for the determination of human A and...

PREA Non-Compliance Letters

In accordance with section 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the following table identifies drug and biological products for which the sponsor has received a Non-Compliance letter and provides links to the Non-Compliance letter...