FDA GFI, Content and Format of 510(k) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, 01/00 2021-09-22T12:31:10+00:00November 20th, 2019|
FDA GFI, Sterilized Convenience Kits for Clinical and Surgical Use, 01/02 2021-09-22T13:50:55+00:00November 20th, 2019|
FDA GFI, Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Prod, 02/08 DRAFT 2021-09-22T14:00:05+00:00November 20th, 2019|
FDA GFI, Submission of Documentation, Parametric Release, Terminally Sterilized by Moist Heat Processes, 02/10 2021-09-22T13:51:48+00:00November 20th, 2019|
FDA Preamble FR Notices, Vol 77 No 86 Amendments to Sterility Test Requirements for Biological Products, 05/12 2021-09-22T15:12:31+00:00November 20th, 2019|
FDA Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories, 07/93 2021-09-22T14:03:30+00:00November 20th, 2019|