Items related to biologics will be added to the top of the list as they are posted on the site.
1/3/2023
Complete List of Licensed Products and Establishments
1/3/2023
Complete List of Substantially Equivalent 510(k) Device Applications
1/3/2023
Complete List of Currently Approved Premarket Approvals (PMAs)
1/3/2023
Complete List of Currently Approved NDA and ANDA Application Submissions
1/3/2023
BK220788 - Aurora Xi Plasmapheresis System
12/27/2022
BK220767 - Lipocube Nano, Liopcube Hybrid I, Lipocube Hybrid II, Centrifuge Container
12/23/2022
Assessing Genetic Heterogeneity in the Context of Genome Editing Off-Targets in Gene Therapy Products - Updated with video recordings.
12/22/2022
BK220785 - Transfer Packs
12/22/2022
December 20, 2022 Approval Letter - ARALAST NP
12/22/2022
Important Information for Blood Establishments and Transfusion Services Regarding Bacterial Contamination of Platelets for Transfusion
12/20/2022
2022 Biological License Application Approvals
12/20/2022
2022 Biological License Application Supplement Noteworthy Approvals
12/20/2022
2022 Biological Device Application Approvals
12/20/2022
November 22, 2022 Summary Basis for Regulatory Action - HEMGENIX
12/20/2022
Voluntary Lot Withdrawals of Allergenic Extract – Peanut (Arachis hypogaea)- For Diagnostic Use Only, Manufactured by ALK-Abelló, Inc. for Increased Reports of False Negative Test Results
12/19/2022
CBER Vacancy: Principal Investigator - Interdisciplinary Scientist
12/19/2022
December 16, 2022 Approval Letter - TENIVAC
12/19/2022
Vaccines and Related Biological Products Advisory Committee January 26, 2023 Meeting Announcement
12/16/2022
December 16, 2022 Approval Letter - ADSTILADRIN
12/16/2022
BK220769 - IH-Ab ID
12/15/2022
Assessing Genetic Heterogeneity in the Context of Genome Editing Off-Targets in Gene Therapy Products - Updated
12/15/2022
Tissue Reference Group - Updated
12/14/2022
Assessing Genetic Heterogeneity in the Context of Genome Editing Off-Targets in Gene Therapy Products - Updated
12/14/2022
BK220738 - DG Reader Net
12/13/2022
December 12, 2022 Approval Letter - VAXCHORA
12/12/2022
November 30, 2022 Summary Basis for Regulatory Action - REBYOTA
12/9/2022
eSubmitter Application History
12/8/2022
December 7, 2022 Approval Letter - DG Gel 8 ABO/Rh (2D)
12/8/2022
Drug Products Labeled as Homeopathic; Guidance for FDA Staff and Industry
12/8/2022
Assessing Genetic Heterogeneity in the Context of Genome Editing Off-Targets in Gene Therapy Products - Updated
12/8/2022
Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff
12/7/2022
2022 Center for Biologics Evaluation and Research (CBER) Science Symposium - Updated
12/7/2022
Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry
12/6/2022
CBER Vacancy: Staff Fellow/Visiting Associate – Biologist
12/5/2022
Clinical Review Memo of Labeling Supplement – SEVENFACT
Content current as of:
01/03/2023
