FDA GFI, Q3C(R8) Impurities: Guidance for Residual Solvents, 12/21 Beatrice Burtsov2022-01-26T15:07:57+00:00January 26th, 2022|
EMA Q&A for MAH on Nitrosamine impurities in human medicinal products, 10/21 Beatrice Burtsov2022-01-26T14:11:37+00:00January 26th, 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, Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products, 07/20 Anna Sandberg2021-09-29T13:29:00+00:00September 29th, 2021|
FDA GFI, Development and Submission of Near Infrared Analytical Procedures, 08/21 Anna Sandberg2021-09-28T14:14:58+00:00September 28th, 2021|
FDA GFI, Compliance Policy Quantity of Bioavailability and Bioequivalence Samples 21CFR320.38(c), 08/20 Felicia Kehr2021-09-22T12:26:21+00:00January 28th, 2021|