| 7/28/2023 |
July 27, 2023 Approval Letter - ERVEBO |
| 7/27/2023 |
BK230811 - Blood Typing Manager, version 3.0 |
| 7/27/2023 |
Cellular, Tissue, and Gene Therapies Advisory Committee Meeting September 27, 2023 Announcement |
| 7/26/2023 |
BK230835 - BD Leucocount Kit; BD FACSuite Clinical BD Leucocount Assay Module; BD FACSLyric Flow Cytometer |
| 7/26/2023 |
Clinical Investigator Status (Biologics)
Updated through 6/30/2023 |
| 7/25/2023 |
BK230826 - WellSky Transfusion 2022 R3 |
| 7/25/2023 |
OTP Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls – April 2023
Transcript added |
| 7/25/2023 |
July 13, 2023 Approval Letter - FLULAVAL QUADRIVALENT |
| 7/24/2023 |
2023 Biological License Application Approvals
Updated through 6/30/2023 |
| 7/24/2023 |
2023 Biological License Application Supplement Noteworthy Approvals
Updated through 6/30/2023 |
| 7/24/2023 |
2023 Biological Device Application Approvals
Updated through 6/30/2023 |
| 7/24/2023 |
July 21, 2023 Approval Letter - BALFAXAR |
| 7/24/2023 |
CBER Cures Vacancy Announcement - IT Specialist (Data Architect), AD-2210, Band E, Office of Regulatory Operations (ORO), Immediate Office of the Director (IOD) |
| 7/21/2023 |
Anthrax |
| 7/21/2023 |
July 20, 2023 Approval Letter - CYFENDUS |
| 7/21/2023 |
June 28, 2023 Summary Basis for Regulatory Action - LANTIDRA |
| 7/21/2023 |
June 29, 2023 Summary Basis for Regulatory Action - ROCTAVIAN |
| 7/21/2023 |
CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals |
| 7/21/2023 |
CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year |
| 7/21/2023 |
Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year |
| 7/20/2023 |
July 20, 2023 Approval Letter - KINRIX |
| 7/20/2023 |
July 20, 2023 Approval Letter - INFANRIX |
| 7/20/2023 |
CBER-Regulated Products: Current Shortages |
| 7/17/2023 |
CBER Cures Vacancy Announcement - Physician, AD-0602-Band C, Office of Biostatistics and Pharmacovigilance (OBPV) |
| 7/14/2023 |
Pfizer-BioNTech COVID-19 Vaccines |
| 7/14/2023 |
Coronavirus (COVID-19) | CBER-Regulated Biologics |
| 7/14/2023 |
CBER Cures Vacancy Announcement – Division Director, AD-0343-Band F, Office of Management (OM), Division of Management Planning and Analysis (DMPA) |
| 7/13/2023 |
General Instructions for Completing the Biological Product Deviation Report (BPDR) - Form FDA 3486
Updated
|
| 7/13/2023 |
Biological Product Deviations
Updated
|
| 7/13/2023 |
Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry |
| 7/13/2023 |
Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry |
| 7/12/2023 |
CBER-Regulated Products: Current Shortages |
| 7/12/2023 |
CBER Cures Vacancy Announcement – Management Analyst, AD-0343-Bands A/B, Office of Management (OM), Division of Human Capital (DHC) |
| 7/11/2023 |
Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development; Draft Guidance for Industry |
| 7/06/2023 |
BioThrax |
| 7/06/2023 |
June 30, 2023 Approval Letter - FluMist Quadrivalent |
| 7/06/2023 |
June 30, 2023 Approval Letter - Flucelvax Quadrivalent |
| 7/05/2023 |
OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products |
| 7/03/2023 |
June 30, 2023 Approval Letter - DENGVAXIA |
| 7/03/2023 |
June 30, 2023 Approval Letter - Flublok Quadrivalent |
| 7/03/2023 |
June 30, 2023 Approval Letter - Afluria (trivalent) and Afluria Quadrivalent |
| 7/03/2023 |
June 30, 2023 Approval Letter - FLUAD QUADRIVALENT |
| 6/30/2023 |
Staff Fellow/Visiting Associate – Chemistry Manufacturing and Controls (CMC) Reviewer |
| 6/30/2023 |
June 30, 2023 Approval Letter - ROCTAVIAN |
| 6/29/2023 |
Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment; Guidance for Industry |
| 6/29/2023 |
June 28, 2023 Approval Letter - LANTIDRA |
| 6/28/2023 |
Principal Investigator: Molecular Biologist with Bioinformatics experience |
| 6/28/2023 |
Content of Premarket Submissions for Device Software Functions; Guidance for Industry and Food and Drug Administration Staff |
| 6/28/2023 |
BK220791 - e-Delphyn Donor |
