| 4/10/2020 | April 10, 2020 Approval Letter - Elecsys HIV Duo |
| 4/9/2020 | Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation - Screening Donors for COVID-19 and Exposure to SARS-CoV-2 and Testing for SARS-CoV-2 |
| 4/9/2020 | User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act |
| 4/8/2020 | Recommendations for Investigational COVID-19 Convalescent Plasma |
| 4/8/2020 | Investigational COVID-19 Convalescent Plasma; Guidance for Industry |
| 4/6/2020 | Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation -- Testing of Stool Donors for Enteropathogenic Escherichia coli and Shigatoxin-Producing Escherichia coli |
| 4/6/2020 | eSubmitter Application History |
| 4/3/2020 | Investigational COVID-19 Convalescent Plasma - Emergency INDs |
| 4/3/2020 | March 30, 2020 Summary Basis for Regulatory Action - DG Gel 8 ABO/Rh (2D) |
| 4/3/2020 | Regenerative Medicine Advanced Therapy Designation |
| 4/3/2020 | April 1, 2020 Untitled Letter - Dynamic Stem Cell Therapy |
| 4/2/2020 | Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency; Guidance for Industry |
| 4/2/2020 | Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Guidance for Industry |
| 4/2/2020 | Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry |
| 4/2/2020 | Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry |
| 4/2/2020 | Expiration Date Extension for Anavip [Crotalidae Immune F(ab’)2 (Equine)]: Lot B-8G-33 through July 31, 2021; Lot B-9B-33 through February 28, 2022; and Lot B-9E-35 through June 30, 2022 |
| 4/2/2020 | Complete List of Licensed Products and Establishments |
| 4/2/2020 | Complete List of Substantially Equivalent 510(k) Device Applications |
| 4/2/2020 | Complete List of Currently Approved Premarket Approvals (PMAs) |
| 4/2/2020 | Complete List of Currently Approved NDA and ANDA Application Submissions |
| 4/1/2020 | Updated Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the Coronavirus Disease 2019 Pandemic |
| 4/1/2020 | CBER Vacancy: Staff Fellow – Bioinformatics (Individualized Cell and Gene Therapies) |
| 4/1/2020 | April 1, 2020 Approval Letter -SEVENFACT |
| 4/1/2020 | April 1, 2020 Approval Letter - Fluzone Quadrivalent |
| 4/1/2020 | March 30 Approval Letter - DG Gel 8 ABO/Rh (2D) |
| 3/27/2020 | Letter to Sponsors, Applicants and Regulated Entities on COVID-19 |
| 3/27/2020 | Summary of FDA & EMA Global Regulators Meeting on Data Requirements Supporting First-in-Human Clinical Trials with SARS-CoV-2 Vaccines |
| 3/26/2020 | Investigational COVID-19 Convalescent Plasma - Emergency INDs Frequently Asked Questions |
| 3/26/2020 | 2020 Biological License Application Supplement Noteworthy Approvals |
| 3/26/2020 | 2020 Biological Device Application Approvals |
| 3/26/2020 | TRG Rapid Inquiry Program (TRIP) |
| 3/24/2020 | March 23, 2020 Approval Letter - VAXELIS |
| 3/24/2020 | Investigational COVID-19 Convalescent Plasma - Emergency INDs |
| 3/23/2020 | March 20, 2020 Approval Letter - Typhim Vi |
| 3/23/2020 | Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19 |
| 3/20/2020 | March 20, 2020 Approval Letter - Fluarix Quadrivalent |
| 3/19/2020 | Updated Instructions for Submitting Lot Release Samples and Protocols for CBER-regulated Products During the COVID-19 Pandemic |
| 3/18/2020 | Complete List of Donor Screening Assay for Infectious Agents and HIV Diagnostic Assays |
| 3/18/2020 | March 13, 2020 Approval Letter - ALBAclone BL 125304-69 et al. |
| 3/18/2020 | March 13, 2020 Approval Letter - ALBAclone STN#125309-64 |
| 3/16/2020 | eSubmitter Application History |
| 3/16/2020 | Cellular, Tissue and Gene Therapies Advisory Committee May 8, 2020 Meeting Announcement |
| 3/13/2020 | Update to March 12, 2020 Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms |
| 3/13/2020 | BK190430 - Anti-D Donor Management and Inventory System (ADIMS) |
| 3/13/2020 | BK190421 - Fenwal Plasmalink Transfer Pack Container with Luer Adapter and No Outlet Ports |
| 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 |
.png)
No hay comentarios:
Publicar un comentario