| 1/31/2024 |
January 16, 2024 Summary Basis for Regulatory Action - CASGEVY |
| 1/30/2024 |
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products; Draft Guidance for Industry |
| 1/29/2024 |
January 26, 2024 Approval Letter - GAMMAGARD LIQUID |
| 1/29/2024 |
Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2024 |
| 1/29/2024 |
January 26, 2024 Approval Letter - Afluria Trivalent and Afluria Quadrivalent |
| 1/29/2024 |
Considerations for the Development of Chimeric Antigen Receptor T Cell Products; Guidance for Industry |
| 1/29/2024 |
Human Gene Therapy Products Incorporating Human Genome Editing; Guidance for Industry |
| 1/29/2024 |
CBER Cures Vacancy Announcement - Mathematical Statistician-Band D, Office of Biostatistics and Pharmacovigilance (OBPV), Division of Biostatistics (DB) |
| 1/26/2024 |
Formal Meetings for CBER-Regulated Products |
| 1/26/2024 |
SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products |
| 1/25/2024 |
Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year
Data as of December 31, 2023 |
| 1/25/2024 |
CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals
Data as of December 31, 2023 |
| 1/25/2024 |
CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year
Data as of December 31, 2023 |
| 1/25/2024 |
CBER Vacancy: Staff Fellow - Researcher-Reviewer |
| 1/24/2024 |
CBER Title 21 Vacancy Announcement - Deputy Office Director, Band F, Office of Blood Research and Review (OBRR), Immediate Office (IO) |
| 1/24/2024 |
January 23, 2024 Safety Labeling Change Notification Letter - TECARTUS (brexucabtagene autoleucel) |
| 1/23/2024 |
January 16, 2024 Untitled Letter - Vitacell Biologics, LLC |
| 1/22/2024 |
January 19, 2024 Safety Labeling Change Notification Letter - ABECMA (idecabtagene vicleucel) |
| 1/22/2024 |
January 19, 2024 Safety Labeling Change Notification Letter - BREYANZI (lisocabtagene maraleucel) |
| 1/22/2024 |
January 19, 2024 Safety Labeling Change Notification Letter - CARVYKTI (ciltacabtagene autoleucel) |
| 1/22/2024 |
January 19, 2024 Safety Labeling Change Notification Letter - KYMRIAH (tisagenlecleucel) |
| 1/22/2024 |
January 19, 2024 Safety Labeling Change Notification Letter - YESCARTA (axicabtagene ciloleucel) |
| 1/22/2024 |
CBER Title 21 Vacancy Announcement – Physician, AD-Band C, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE), Division of Clinical Evaluation General Medicine (DCEGM), General Medicine Branch (GMB) |
| 1/19/2024 |
CBER 2024 Orphan Approvals |
| 1/19/2024 |
December 22, 2023 Summary of the Safety and Effectiveness Data - RECELL Autologous Cell Harvesting Device |
| 1/18/2024 |
CBER Title 21 Vacancy Announcement – Associate Director of Labeling, AD-Band D, Office of Vaccines Research and Review (OVRR), Division of Clinical and Toxicology Review (DCTR) |
| 1/18/2024 |
CBER Cures Vacancy Announcement - Data Scientist, AD-0301-Band C, Office of Regulatory Operations (ORO), Division of Informatics (DI) |
| 1/17/2024 |
December 22, 2023 Approval Letter - RECELL Autologous Cell Harvesting Device |
| 1/16/2024 |
January 16, 2024 Approval Letter - CASGEVY (STN 125785) |
| 1/16/2024 |
January 12, 2024 Approval Letter - HYQVIA |
| 1/16/2024 |
CBER Cures Vacancy Announcement - Branch Chief, AD-0602-Band D, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE) |
| 1/12/2024 |
Common Ingredients in FDA-Approved Vaccines |
| 1/11/2024 |
January 10, 2024 Approval Letter - ELEVIDYS |
| 1/11/2024 |
Clinical Investigator Status (Biologics)
Updated through 12/31/2023 |
| 1/11/2024 |
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile; Guidance for Industry and Food and Drug Administration Staff |
| 1/10/2024 |
eSubmitter Application - Version 3.75.00 - Released 12/08/2023 |
| 1/9/2024 |
SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA) |
| 1/9/2024 |
Staff Fellow/Visiting Associate – Pharmacology/Toxicology Reviewer |
| 1/5/2024 |
December 8, 2023 Summary Basis for Regulatory Action - LYFGENIA |
| 1/5/2024 |
January 4, 2024 Approval Letter - RECOTHROM |
| 1/4/2024 |
December 15, 2023 Summary Basis for Regulatory Action - ALYGLO |
| 1/3/2024 |
December 8, 2023 Summary Basis for Regulatory Action - CASGEVY |
| 1/2/2024 |
Complete List of Licensed Products and Establishments
Update |
| 1/2/2024 |
Complete List of Substantially Equivalent 510(k) Device Applications
Update |
| 1/2/2024 |
Complete List of Currently Approved Premarket Approvals (PMAs)
Update |
| 1/2/2024 |
Complete List of Currently Approved NDA and ANDA Application Submissions
Update |
