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|
ICH Guideline, Analytical Procedure Development, Q14, DRAFT, 04/22 Beatrice Burtsov2022-11-08T13:14:37+00:00November 8th, 2022|
FDA GFI, Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program, DRAFT, 05/22 Beatrice Burtsov2022-09-07T15:32:08+00:00September 7th, 2022|
FDA GFI, Risk Management Plans to Mitigate the Potential for Drug Shortages, DRAFT, 05/22 Beatrice Burtsov2022-09-07T15:19:16+00:00September 7th, 2022|
ICH Guideline, Validation of Analytical Procedures, R2 DRAFT, 03/22 Beatrice Burtsov2022-10-05T15:26:37+00:00April 5th, 2022|
FDA GFI, Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA, DRAFT, 08/21 Beatrice Burtsov2022-01-28T10:12:09+00:00January 28th, 2022|