| 5/3/2024 |
Transcript for the Biomarker-driven Drug Development for Allergic Diseases and Asthma Public Workshop |
| 5/2/2024 |
Complete List of Licensed Products and Establishments
Update |
| 5/2/2024 |
Complete List of Substantially Equivalent 510(k) Device Applications
Update |
| 5/2/2024 |
Complete List of Currently Approved Premarket Approvals (PMAs)
Update |
| 5/2/2024 |
Complete List of Currently Approved NDA and ANDA Application Submissions
Update |
| 5/1/2024 |
May 1, 2024 Approval Letter - ADSTILADRIN |
| 5/1/2024 |
CBER Title 21 Vacancy Announcement – Management Analyst, AD-0343-Band W/Y, Office of Management (OM), Division of Program Services (DPS), Program Services Branch (PSB) |
| 5/1/2024 |
CBER Title 21 Vacancy Announcement – Deputy Division Director, AD-0601 - Band E, Office of Vaccines Research and Review (OVRR), Division of Bacterial Parasitic and Allergenic Products (DBPAP) |
| 4/30/2024 |
User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act
Update |
| 4/30/2024 |
Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels; Guidance for Industry |
| 4/29/2024 |
Title 21 Vacancy Announcement- Training Specialist, AD-1712-B and C- Center for Biologics Evaluation and Research (CBER), Office of Communication Outreach and Development (OCOD), Division of Manufactures Assistance and Training (DMAT), Career Development and Directed Training Branch (CDDTB) |
| 4/29/2024 |
Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products; Draft Guidance for Industry |
| 4/29/2024 |
Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry |
| 4/26/2024 |
April 26, 2024 Approval Letter - IMOVAX RABIES |
| 4/26/2024 |
April 25, 2024 Approval Letter - BEQVEZ |
| 4/26/2024 |
Important Information for Human Cell, Tissue, and Cellular and Tissue-based Product (HCT/P) Establishments Regarding the Recall of Certain Saline and Sterile Water Medical Products by Nurse Assist |
| 4/26/2024 |
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Draft Guidance for Industry, IRBs, and Clinical Investigators |
| 4/26/2024 |
BK241060 - Arthrex Thrombinator System |
| 4/25/2024 |
April 12, 2024 Approval Letter - YESCARTA |
| 4/25/2024 |
April 12, 2024 Approval Letter - KYMRIAH |
| 4/25/2024 |
April 12, 2024 Approval Letter - TECARTUS |
| 4/25/2024 |
Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Draft Guidance for Industry, IRBs, and Clinical Investigators |
| 4/25/2024 |
April 24, 2024 Approval Letter - AUDENZ |
| 4/24/2024 |
FDA CBER Webinar: Considerations for the Development of CAR T Cell Products
Webinar transcript published |
| 4/24/2024 |
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products - Questions and Answers; Draft Guidance for Industry |
| 4/23/2024 |
eSubmitter Application History
Updated |
| 4/23/2024 |
CBER Title 21 Vacancy Announcement – Branch Chief, Band D, Office of Management (OM), Division of Management Planning and Analysis (DMPA), Planning, Performance and Formulation Branch (PPFB) |
| 4/22/2024 |
April 19, 2024 Approval Letter - SPIKEVAX |
| 4/22/2024 |
CBER Cures Vacancy Announcement - Branch Chief, AD-1001-Band D, Office of Communication, Outreach and Development (OCOD), Division of Communication and Consumer Affairs (DCCA), Consumer Affairs Branch (CAB) |
| 4/19/2024 |
Clinical Investigator Status (Biologics)
Updated |
| 4/19/2024 |
BK230980 - BD Vacutainer K2EDTA Blood Collection Tubes |
| 4/19/2024 |
April 18, 2024 Approval Letter - Octaplas |
| 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 |
| 4/12/2024 |
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 |
| 4/4/2024 |
CY 2023 Report from the Director |
| 4/4/2024 |
CBER-Regulated Products: Current Shortages
Rho(D) Immune Globulin (Human) |
