| 6/11/2020 | Assessing Immunogenicity of Products for Gene Therapy and T cell Therapy |
| 6/11/2020 | Investigating the Effects of Cell-Materials Interactions on the Safety and Effectiveness of Cell-Based Products |
| 6/11/2020 | June 9, 2020 Approval Letter - Kedbumin |
| 6/11/2020 | BK200475 - ALYX Component Collection System |
| 6/11/2020 | BK200482 - Blood Product Administration Module Version 3-2020 |
| 6/9/2020 | BK190393 - Aeon CPKit |
| 6/5/2020 | New Approaches to the Development and Evaluation of Human Cytomegalovirus (HCMV) Vaccines |
| 6/3/2020 | OraQuick In-Home HIV Test Fact Sheet |
| 6/1/2020 | Complete List of Licensed Products and Establishments |
| 6/1/2020 | Complete List of Substantially Equivalent 510(k) Device Applications |
| 6/1/2020 | Complete List of Currently Approved Premarket Approvals (PMAs) |
| 6/1/2020 | Complete List of Currently Approved NDA and ANDA Application Submissions |
| 5/28/2020 | Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 |
| 5/27/2020 | May 14, 2020 Approval Letter - CUTAQUIG |
| 5/27/2020 | May 18, 2020 Approval Letter - YESCARTA |
| 5/22/2020 | Identification of Targets for Development of Vaccines and Biological Therapies Against Gastrointestinal Pathogens |
| 5/21/2020 | BK200472 - BACT/ALERT BPA Culture Bottle; BACT/ALERT BPN Culture Bottle |
| 5/21/2020 | HCT/P Inspection Information |
| 5/19/2020 | Annual Summary for Fiscal Year 2019 |
| 5/19/2020 | Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma; Guidance for Industry |
| 5/18/2020 | 2020 Biological License Application Approvals |
| 5/18/2020 | 2020 Biological Device Application Approvals |
| 5/14/2020 | April 28, 2020 Untitled Letter - ValeoMD |
| 5/14/2020 | May 13, 2020 Approval Letter - FLUAD |
| 5/14/2020 | April 22, 2020 Summary Basis for Regulatory Action - MenQuadfi |
| 5/13/2020 | May 12, 2020 Approval Letter - Flublok |
| 5/12/2020 | May 11, 2020 Untitled Letter - Sparrow Health & Performance, LLC |
| 5/12/2020 | Transcript for the Facilitating End-to-End Development of Individualized Therapeutics Public Workshop |
| 5/12/2020 | May 11, 2020 Approval Letter - Anti - M (Murine Monoclonal IgG) STN#125308-56 |
| 5/12/2020 | eSubmitter Application History |
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