FDA GFI, Completeness Assessments for Type II API DMFs Under GDUFA, 10/17 Beatrice Burtsov2022-12-06T12:53:31+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, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, DRAFT, 04/22 Beatrice Burtsov2022-11-16T10:40:03+00:00November 16th, 2022|
FDA GFI, Bioavailability Studies Submitted in NDAs or INDs — General Considerations, 04/22 Beatrice Burtsov2022-11-16T10:32:41+00:00November 16th, 2022|
FDA GFI, Drug and Biologiacal Products that Contain Nanomaterial, 04/22 Beatrice Burtsov2022-11-09T10:28:26+00:00November 9th, 2022|
ICH Guideline, Guideline for Elemental Impurities, Q3D(R2), 04/22 Beatrice Burtsov2022-11-09T08:56:55+00:00November 9th, 2022|