| 12/11/2019 | December 10, 2019 - Approval Letter - Anti-D (RH1) IgM/IgG 125621/2 |
| 12/11/2019 | December 10, 2019 Approval Letter - DG Gel 8 Anti-IgG (Rabbit), DG Gel Cards - STN# 125445/32 |
| 12/11/2019 | CBER Vacancy: Postdoctoral Fellow/Visiting Associate – Viral Vaccines (Biologist), RG-0401 |
| 12/9/2019 | Complete List of Licensed Products and Establishments |
| 12/9/2019 | Complete List of Substantially Equivalent 510(k) Device Applications |
| 12/9/2019 | Complete List of Currently Approved Premarket Approvals (PMAs) |
| 12/9/2019 | Complete List of Currently Approved NDA and ANDA Application Submissions |
| 12/9/2019 | December 6, 2019 Approval Letter - TENIVAC |
| 12/9/2019 | BK190333 - Terumo Operational Medical Equipment Software (TOMEs), Version 7.1 |
| 12/9/2019 | CBER-Regulated Products: Current Shortages |
| 12/6/2019 | Public Safety Notification on Exosome Products |
| 12/5/2019 | December 3, 2019 Approval Letter - Panoscreen EXTEND |
| 12/5/2019 | User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act |
| 12/5/2019 | Influenza Vaccine for the 2019-2020 Season |
| 12/5/2019 | Job Vacancy Announcement: Physician, Division of Epidemiology (DE) - Title 38(F) Physician (GP-0602) |
| 12/4/2019 | December 3, 2019 Approval Letter - Data-Cyte Plus 2, and Data-Cyte Extend 0.8 % Reagent Red Blood Cells |
| 12/4/2019 | BK190389 - ALBAcheck BGS Monoclonal Control |
| 12/3/2019 | November 25, 2019 Untitled Letter - Chara Biologics, Inc. |
| 12/3/2019 | Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 |
| 12/2/2019 | March 3, 2020 Workshop - Facilitating End-to-End Development of Individualized Therapeutics |
| 11/29/2019 | November 26, 2019 Approval Letter - Pneumovax 23 |
| 11/27/2019 | November 25, 2019 Order to Cease Manufacturing - Gynecology, Reproductive Endocrinology and Fertility Institute (GREFI) |
| 11/27/2019 | Influenza Vaccine for the 2019-2020 Season |
| 11/25/2019 | FDA Zika virus reference panel for molecular-based diagnostic devices supports product testing for Emergency Use Authorization and 510(k) submissions |
| 11/22/2019 | November 20, 2019 Untitled Letter - RichSource Stem Cells, Inc. |
| 11/21/2019 | Influenza Vaccine for the 2019-2020 Season |
| 11/18/2019 | 2019 Biological Device Application Approvals |
| 11/18/2019 | 2019 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals |
| 11/18/2019 | November 7, 2019 - Anti-Fyb (Murine Monoclonal) (Recombinant) |
| 11/18/2019 | November 7, 2019 - Anti-Fya (Murine Monoclonal) (Recombinant) |
| 11/15/2019 | SOPP 8116: Use of Electronic Signatures for Regulatory Documents |
| 11/14/2019 | Influenza Vaccine for the 2019-2020 Season |
|
| 11/13/2019 | November 12, 2019 Approval Letter - Rotarix |
| 11/13/2019 | CBER-Regulated Products: Current Shortages |
| 11/12/2019 | BK190349 - RD2 System |
No hay comentarios:
Publicar un comentario