| 4/18/2024 |
FDA Requires Boxed Warning for T cell Malignancies Following Treatment with BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies |
| 4/18/2024 |
OTP Town Hall: CMC Readiness for Gene Therapy BLAs |
| 4/17/2024 |
BK230814 - SmartDMS |
| 4/16/2024 |
April 4, 2024 Clinical Review - ABECMA |
| 4/16/2024 |
April 4, 2024 Statistical Review - ABECMA |
| 4/16/2024 |
SOPP 8101.2: Scheduling and Documentation of Liaison Meetings with Industry Trade Organizations |
| 4/15/2024 |
CBER Title 21 Vacancy Announcement – Project Manager, AD-0301-Band B, Office of Regulatory Operations (ORO), Division of Regulatory Operations and Programs (DROP), Regulatory Programs Branch (RPB) |
| 4/12/2024 |
Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year
Data as of March 31, 2024 |
| 4/12/2024 |
CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals
Data as of March 31, 2024 |
| 4/12/2024 |
CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year
Data as of March 31, 2024 |
| 4/12/2024 |
Coronavirus (COVID-19) | CBER-Regulated Biologics |
| 4/12/2024 |
April 05, 2024 Statistical Review - CARVYKTI |
| 4/12/2024 |
SOPP 8119: Use of Email for Regulatory Communications |
| 4/12/2024 |
CBER Vacancy: Staff Fellow/Visiting Associate – Pharmacology/Toxicology Reviewer |
| 4/11/2024 |
Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development
May 29 - 30, 2024 |
| 4/10/2024 |
eSubmitter Application History
Updated |
| 4/10/2024 |
April 5, 2024 Approval Letter - SKYSONA |
| 4/9/2024 |
BK230825 - ALYX 2RBC-LR Kit | FDA |
| 4/8/2024 |
March 18, 2024 Summary Basis for Regulatory Action - LENMELDY |
| 4/8/2024 |
April 5, 2024 Approval Letter - CARVYKTI |
| 4/8/2024 |
April 4, 2024 Approval Letter - ABECMA |
| 4/8/2024 |
CBER Title 21 Vacancy Announcement – Pharmacologist, AD-0405 - Band C, Office of Vaccines Research and Review (OVRR), Division of Clinical and Toxicology Review (DCTR), Toxicology Staff (TS) |
| 4/4/2024 |
CY 2023 Report from the Director |
| 4/4/2024 |
CBER-Regulated Products: Current Shortages
Rho(D) Immune Globulin (Human) |
| 4/3/2024 |
March 22, 2024 Clinical Memo - WILATE |
| 4/3/2024 |
BK230968 - 3C OrthoPatch Device |
| 4/2/2024 |
Complete List of Licensed Products and Establishments
Update |
| 4/2/2024 |
Complete List of Substantially Equivalent 510(k) Device Applications
Update |
| 4/2/2024 |
Complete List of Currently Approved Premarket Approvals (PMAs)
Update |
| 4/2/2024 |
Complete List of Currently Approved NDA and ANDA Application Submissions
Update |
| 4/01/2024 |
Providing Regulatory Submissions in Electronic Format: IND Safety Reports; Guidance for Industry |
| 4/1/2024 |
CBER Cures Vacancy Announcement – Branch Chief, AD-0696-Band D - Office of Compliance and Biologics Quality (OCBQ)/Division of Manufacturing and Product Quality (DMPQ)/Manufacturing Review Branch 1 (MRB1) |
| 4/1/2024 |
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) |
| 3/29/2024 |
Statistical Review - IXINITY |
| 3/29/2024 |
Clinical Review Memo - IXINITY |
| 3/29/2024 |
Clinical Pharmacology Review - IXINITY |
| 3/29/2024 |
March 28, 2024 Approval Letter - ANDEXXA |
| 3/27/2024 |
March 27, 2024 Approval Letter - FEIBA |
| 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 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) |
