FDA GFI, Q&A on Biosimilar Development and the BPCI Act, DRAFT, Revision 3, 09/21 Beatrice Burtsov2022-01-28T10:07:14+00:00January 28th, 2022|
FDA GFI, Notifying FDA of Permanent Discontinuance or Interruption in Manufacturing of a Device, DRAFT, 01/22 Beatrice Burtsov2022-01-28T09:26:39+00:00January 28th, 2022|
FDA GFI, Inspection of Injectable Products for Visible Particulates, DRAFT, 12/21 Felicia Kehr2022-01-19T09:57:35+00:00January 19th, 2022|
FDA GFI, Microbiological Quality Considerations in Non-sterile Drug Manufacturing, DRAFT, 09/21 Anna Sandberg2021-11-22T14:15:27+00:00November 22nd, 2021|
FDA GFI, Select Updates for UDI: Policy Regarding Global UDI Database Requirements for Certain Devices, DRAFT, 10/21 Anna Sandberg2021-10-28T13:42:51+00:00October 28th, 2021|
FDA GFI, Feasibility & Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus, DRAFT, 05/21 Anna Sandberg2021-09-30T08:16:05+00:00September 30th, 2021|