FDA GFI, Content of Human Factors Information in Medical Device Marketing Submissions, DRAFT, 12/22 Anastasija Eschricht2023-02-24T09:18:26+00:00February 24th, 2023|
FDA GFI, Best Practices for Communication Between IND Sponsors and FDA During Drug Development, 12/17 Anastasija Eschricht2023-02-24T09:13:59+00:00February 24th, 2023|
ICH Guideline Continuous Manufacturing of Drug Substances and Drug Products Q13, 11/22 Anastasija Eschricht2023-02-24T09:11:24+00:00February 24th, 2023|
EMA Guidance, Recommendation paper on decentralised elements in clinical trials, 12/22 Anastasija Eschricht2023-02-24T09:09:11+00:00February 24th, 2023|
MDCG 2022 20 Substantial modification of performance study under Regulation (EU) 2017/746, 12/22 Anastasija Eschricht2023-02-24T08:57:56+00:00February 24th, 2023|
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|
