| 3/26/2024 |
CBER Title 21 Vacancy Announcement – Deputy Division Director, Band E, Office of Vaccines Research and Review (OVRR), Division of Review Management and Regulatory Review (DRMRR) |
| 3/25/2024 |
March 18, 2024 Summary Basis for Regulatory Action - Cobas Malaria |
| 3/22/2024 |
SOPP 8704: Managing MDUFA User Fee Payments and Billing Activities |
| 3/22/2024 |
March 22, 2024 Approval Letter - IXINITY |
| 3/22/2024 |
March 22, 2024 Approval Letter - WILATE |
| 3/21/2024 |
BK231036 - NexLynk DMS Donor Management System 4.10.0 |
| 3/20/2024 |
Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products; Draft Guidance for Industry |
| 3/20/2024 |
March 19, 2024 Approval Letter - cobas® Malaria |
| 3/19/2024 |
Artificial Intelligence and Machine Learning (AI/ML) for Biological and Other Products Regulated by CBER |
| 3/18/2024 |
March 18, 2024 Approval Letter - LENMELDY |
| 3/18/2024 |
March 14, 2024 Approval Letter - BREYANZI |
| 3/18/2024 |
March 14, 2024 Approval Letter - ABRYSVO (STN 125769) |
| 3/18/2024 |
Enforcement Actions (CBER)
Updated |
| 3/18/2024 |
CBER Title 21 Vacancy Announcement - Lead Management Analyst (Outreach and DEIA Team Lead), Band C, Office of Management (OM), Division of Human Capital (DHC), Management Services Branch (MSB) |
| 3/18/2024 |
CBER Cures Vacancy Announcement - Lead Management Analyst (Retention and Recognition Team Lead), AD-0343-Band C, Office of Management (OM), Division of Human Capital (DHC), Management Services Branch (MSB) |
| 3/18/2024 |
CBER Cures Vacancy Announcement - Budget Analyst, AD-0560-Band A/B, Office of Management (OM), Division of Acquisition and Budget Resources (DABR), Budget Planning and Execution Branch (BPEB) |
| 3/15/2024 |
January 23, 2024 Clinical Review Memo - Wilate |
| 3/15/2024 |
eSubmitter Application History
Updated |
| 3/15/2024 |
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff |
| 3/15/2024 |
March 14, 2024 Approval Letter - GARDASIL 9 |
| 3/14/2024 |
March 12, 2024 Untitled Letter - Amnion Florida, LLC |
| 3/14/2024 |
BK231035 - Rika Plasma Donation System (V2.1) |
| 3/13/2024 |
2024 Biological License Application Approvals
Updated as of 2/29/2024 |
| 3/13/2024 |
2024 Biological Device Application Approvals
Updated as of 2/29/2024 |
| 3/13/2024 |
Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act; Draft Guidance for Industry and Food and Drug Administration Staff |
| 3/13/2024 |
CBER Cures Vacancy Announcement - Lead Physician, AD-0602-Band D, Office of Therapeutic Products (OTP), Division of Clinical Evaluation Hematology (DCEH), Benign Hematology Branch (BHB) |
| 3/12/2024 |
Early Alzheimer’s Disease: Developing Drugs for Treatment; Draft Guidance for Industry |
| 3/12/2024 |
CBER Vacancy: Staff Fellow/Visiting Associate – Interdisciplinary Scientist |
| 3/11/2024 |
February 28, 2024 Summary Basis for Regulatory Action - Elecsys Anti-HCV II |
| 3/11/2024 |
Blood Products Advisory Committee May 9, 2024 Meeting Announcement |
| 3/8/2024 |
February 15, 2024 Summary Basis for Regulatory Action - AMTAGVI |
| 3/7/2024 |
CBER 2024 Orphan Approvals |
| 3/7/2024 |
February 26, 2024 Summary Basis for Regulatory Action - Elecsys Anti-HBc II |
| 3/7/2024 |
February 21, 2024 Summary Basis for Regulatory Action - Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm |
| 3/5/2024 |
Use of Trivalent Influenza Vaccines for the 2024-2025 U.S. Influenza Season |
| 3/5/2024 |
March 1, 2024 Approval Letter - YESCARTA |
| 3/5/2024 |
Vaccines and Related Biological Products Advisory Committee May 16, 2024 Meeting Announcement
Updated: March 5, 2024 |
| 3/5/2024 |
CBER Title 21 Vacancy Announcement – Deputy Division Director, AD-0601-Band E, Center for Biologics Evaluation and Research (CBER), Office of Vaccines Research and Review (OVRR), Division of Bacterial Parasitic and Allergenic Products (DBPAP) |
| 3/4/2024 |
February 29, 2024 Approval Letter - Kedbumin |
| 3/4/2024 |
March 1, 2024 Approval Letter - AFLURIA |
| 3/4/2024 |
Summary of Safety and Probable Benefit (SSPB) - QUELIMMUNE |
| 3/4/2024 |
March 1, 2024 Approval Letter - BIVIGAM |
| 3/4/2024 |
March1, 2024 Approval Letter - ASCENIV |
| 3/4/2024 |
Complete List of Licensed Products and Establishments
Update |
| 3/4/2024 |
Complete List of Substantially Equivalent 510(k) Device Applications
Update |
| 3/4/2024 |
Complete List of Currently Approved Premarket Approvals (PMAs)
Update |
| 3/4/2024 |
Complete List of Currently Approved NDA and ANDA Application Submissions
Update |
| 3/1/2024 |
Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Guidance for Industry |
| 3/1/2024 |
Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards |
| 3/1/2024 |
Information for Health Professionals on “Partial Heart Transplantation" |
| 2/29/2024 |
February 28, 2024 Approval Letter - ESPEROCT |
| 2/29/2024 |
February 28, 2024 Approval Letter - Elecsys Anti-HCV II |
| 2/28/2024 |
February 21, 2024 Approval Letter - Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm |
| 2/28/2024 |
February 23, 2024 Untitled Letter - Oregon Medical Centers, LLC |
