12/4/2023 |
December 1, 2023 Approval Letter - Wilate |
12/01/2023 |
December 1, 2023 Approval Letter - ODACTRA |
11/30/2023 |
November 9, 2023 Summary Basis for Regulatory Action - ADZYNMA |
11/30/2023 |
November 29, 2023 Approval Letter - Fluzone |
11/29/2023 |
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention; Guidance for Industry |
11/29/2023 |
Warrior Families: Advancing Regenerative Medicine Through Science Webinar Transcript |
11/29/2023 |
Warrior Families: Advancing Regenerative Medicine Through Science Presentation Slides |
11/28/2023 |
Translation of Good Laboratory Practice Study Reports: Questions and Answers; Draft Guidance for Industry |
11/28/2023 |
BK231004- Blood Product Questionnaire Module |
11/28/2023 |
FDA Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies |
11/27/2023 |
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry
(Updated November 27, 2023) |
11/27/2023 |
November 17, 2023 Summary Basis for Regulatory Action - PENBRAYA |
11/27/2023 |
SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products |
11/21/2023 |
CBER CURES Vacancy Announcement – Deputy Office Director, AD-Band F, Office of Vaccines Research and Review (OVRR), Immediate Office of the Director (IOD)
Updated closing date |
11/20/2023 |
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff |
11/15/2023 |
CBER 2023 Orphan Approvals (new BLAs) - Updated |
11/14/2023 |
eSubmitter Application History |
11/13/2023 |
November 9, 2023 Approval Letter - PALFORZIA |
11/13/2023 |
CBER Cures Vacancy Announcement - Biological Regulatory Specialist, Band C, CBER/ORO/IOD/CMCT |
11/09/2023 |
November 9, 2023 Approval Letter - ADZYNMA |
11/09/2023 |
November 9, 2023 Approval Letter - IXCHIQ |
11/7/2023 |
BK230840- Elecsys Anti-CMV; PreciControl Anti-CMV; PreciControl Release Anti-CMV |
11/7/2023 |
BK230986 - ePROGESA v5.0.3 |
11/6/2023 |
Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices; Guidance for Industry and Food and Drug Administration Staff |
11/3/2023 |
WCBP Symposium 2024
Event date: January 23 - 25, 2024 |
11/3/2023 |
CBER Staff Fellow - Product/Chemistry, Manufacturing and Controls (CMC) Reviewer |
11/2/2023 |
Workshop for the Identification and Standardization of Methods for Assessing Gene Therapy Product Activity and Comparability and the Evaluation of T-Cell Therapies |
11/1/2023 |
Important Information About the Correct Dosage and Administration of Moderna COVID-19 Vaccine (2023-2024 Formula) for Individuals 6 Months Through 11 Years of Age |
11/1/2023 |
Complete List of Licensed Products and Establishments
Updated as of 10/31/2023 |
11/1/2023 |
Complete List of Substantially Equivalent 510(k) Device Applications
Updated as of 10/31/2023 |
11/1/2023 |
Complete List of Currently Approved Premarket Approvals (PMAs)
Updated as of 10/31/2023 |
11/1/2023 |
Complete List of Currently Approved NDA and ANDA Application Submissions
Updated as of 10/31/2023 |
11/1/2023 |
CBER Cures Vacancy Announcement – Division Director, AD-Band F, Office of Therapeutic Products (OTP), Office of Cellular Therapy & Human Tissue CMC (OCTHT), Division of Human Tissue (DHT) |
10/30/2023 |
October 27, 2023 Approval Letter - HAVRIX |
10/30/2023 |
October 27, 2023 Approval Letter - ENGERIX-B |
10/27/2023 |
October 27, 2023 Approval Letter - BOOSTRIX |
10/27/2023 |
October 27, 2023 Approval Letter - KINRIX |
10/27/2023 |
October 27, 2023 Approval Letter - INFANRIX |
10/26/2023 |
CBER Cures Vacancy Announcement - Deputy Office Director, AD-Band F, Office of Vaccines Research and Review (OVRR), Immediate Office of the Director (IOD) |
10/26/2023 |
October 16, 2023 Summary Basis for Regulatory Action - Elecsys HTLV-I/II |
10/25/2023 |
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities; Draft Guidance for Industry; Draft Guidance for Industry |
10/24/2023 |
Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers; Draft Guidance for Industry |
10/23/2023 |
Important Information About Directed Blood Donations that are Not Medically Indicated |
10/20/2023 |
October 20, 2023 Approval Letter - PENBRAYA |
10/20/2023 |
2023 Biological License Application Approvals
Updated as of 9/30/2023 |
10/20/2023 |
2023 Biological License Application Supplement Noteworthy Approvals
Updated as of 9/30/2023 |
10/20/2023 |
2023 Biological Device Application Approvals
Updated as of 9/30/2023 |
10/19/2023 |
Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry |
10/19/2023 |
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry |
10/18/2023 |
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol; Guidance for Industry |
10/18/2023 |
October 17, 2023 Approval Letter - ZOLGENSMA |
10/18/2023 |
Transcript for the FDA CBER OTP Listening Meeting: Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products |
10/17/2023 |
October 17, 2023 Approval Letter - COMIRNATY |
10/17/2023 |
October 17, 2023 Approval Letter - Elecsys HTLV-I/II |
10/17/2023 |
Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Guidance for Industry |