MDCG 2022 19 Performance study application/notification documents under Regulation (EU) 2017/746, 12/22 Anastasija Eschricht2023-02-24T08:52:19+00:00February 24th, 2023|
FDA GFI, SVP Drugs and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations, 12/22 Anastasija Eschricht2023-02-24T08:45:50+00:00February 24th, 2023|
FDA GFI, Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial, 11/22 Anastasija Eschricht2023-02-08T10:21:45+00:00February 8th, 2023|
FDA GFI, Statistical Approaches to Establishing Bioequivalence, DRAFT, 12/22 Anastasija Eschricht2022-12-06T13:31:20+00:00December 6th, 2022|
MDCG 2021 28 Substantial modification of clinical investigation under Medical Device Regulation, 12/21 Beatrice Burtsov2022-11-30T12:56:39+00:00November 30th, 2022|
FDA GFI, Bioavailability Studies Submitted in NDAs or INDs — General Considerations, 04/22 Beatrice Burtsov2022-11-16T10:32:41+00:00November 16th, 2022|