| 3/13/2020 | CBER-Regulated Products: Resolved Shortages |
| 3/12/2020 | Biological Product Deviation Reporting and HCT/P Deviation Reporting - Deviation Codes |
| 3/12/2020 | Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms |
| 3/12/2020 | Biological Product Deviation Reporting for Blood and Plasma Establishments; Guidance for Industry |
| 3/11/2020 | Updated Information for Blood Establishments Regarding the Novel Coronavirus Outbreak |
| 3/11/2020 | BK190434 - ORTHO CONNECT 3.0 |
| 3/11/2020 | Regulatory Submissions - Electronic and Paper |
| 3/3/2020 | Complete List of Licensed Products and Establishments |
| 3/3/2020 | Complete List of Substantially Equivalent 510(k) Device Applications |
| 3/3/2020 | Complete List of Currently Approved Premarket Approvals (PMAs) |
| 3/3/2020 | Complete List of Currently Approved NDA and ANDA Application Submissions |
| 3/2/2020 | Statistical Review - FLUAD QUADRIVALENT |
| 3/2/2020 | February 20, 2020 Clinical Review - FLUAD QUADRIVALENT |
| 2/27/2020 | February 26, 2020 Approval Letter - ODACTRA |
| 2/25/2020 | Synonymous mutation increases in vitro production and activity of enzyme that reduces blood clotting |
| 2/25/2020 | Determining susceptibility of influenza A viruses to first-line immune response by pulmonary surfactant protein D (SP-D) |
| 2/25/2020 | Universal test for assessing potency of inactivated poliovirus vaccines could facilitate their global production and availability |
| 2/25/2020 | Allergenic Products Advisory Committee May 15, 2020 Meeting Announcement |
| 2/21/2020 | February 21, 2020 Approval Letter - FLUAD QUADRIVALENT |
| 2/21/2020 | February 20, 2020 Approval Letter - Gardasil 9 |
| 2/21/2020 | Final Agenda - Facilitating End-to-End Development of Individualized Therapeutics |
| 2/21/2020 | February 20, 2020 Approval Letter - MENVEO |
| 2/20/2020 | January 31, 2020 Summary Basis for Regulatory Action - AUDENZ |
| 2/19/2020 | January 31, 2020 Summary Basis for Regulatory Action - PALFORZIA |
| 2/19/2020 | 2020 Biological Device Application Approvals |
| 2/19/2020 | 2020 Biological License Application Supplement Noteworthy Approvals |
| 2/19/2020 | 2020 Biological License Application Approvals |
| 2/14/2020 | Direct Recall Classification Program |
| 2/14/2020 | Electronic Submission of Biological Product Deviation Reports (eBPDR) |
| 2/14/2020 | Biological Product Deviations |
| 2/14/2020 | General Instructions for Completing the Biological Product Deviation Report (BPDR) - Form FDA 3486 |
| 2/14/2020 | Instructions for Using the eBPDR System |
| 2/14/2020 | Important Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the 2019 Novel Coronavirus Outbreak |
| 2/14/2020 | February 13, 2020 Approval Letter - VAXCHORA |
| 2/14/2020 | Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020 |
| 2/13/2020 | BK190317 - PurePRP SupraPhysiologic Concentrating System |
| 2/13/2020 | February 10, 2020 Untitled Letter - RejuvaYou Medical Corporation |
| 2/13/2020 | February 12, 2020 Approval Letter - Procleix Babesia Assay |
| 2/13/2020 | Blood Products Advisory Committee April 2-3, 2020 Meeting Announcement |
| 2/13/2020 | 23rd US-Japan Cellular and Gene Therapy Conference |
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