Items related to biologics will be added to the top of the list as they are posted on the site.
12/23/2021
Regulatory Submissions in Electronic Format for CBER-Regulated Products
12/22/2021
Regulatory Submissions in Electronic and Paper Format for CBER-Regulated Products
12/20/2021
Section 8400: Marketing Applications
12/20/2021
2021 Biological Device Application Approvals
12/20/2021
2021 Biological License Application Approvals
12/20/2021
2021 Biological License Application Supplement Noteworthy Approvals
12/20/2021
December 16, 2021 Untitled Letter - Aspen Institute for Regenerative Medicine and Anti-Aging, LLC
12/17/2021
BK210639 - Stem Kit Reagents, stemCXP System
12/16/2021
December 16, 2021 Approval Letter - COMIRNATY
12/16/2021
Transcripts for the Regenerative Medicine 101 Webinar: Information for Patients, Caregivers & Advocates
12/16/2021
CBER Advanced Technologies Program Extramural Research Funding
12/13/2021
User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act
12/10/2021
December 9, 2021 Approval Letter - Anti-D (RH1) IgM/IgG - 125615/8*
12/10/2021
Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency; Guidance for Industry and Health Care Professionals
12/10/2021
PREA Non-Compliance Letters
12/9/2021
December 8, 2021 Approval Letter - IMLYGIC
12/9/2021
eSubmitter Application History
12/9/2021
November 30, 2021 Summary Basis for Regulatory Action - PREHEVBRIO
12/8/2021
Slides for the Regenerative Medicine 101 Webinar: Information for Patients, Caregivers & Advocates
12/8/2021
Zoom Webinar Recording for Regenerative Medicine 101 Webinar
12/8/2021
CBER Vacancy: Staff Fellow - Cell and Gene Therapy Reviewer
12/7/2021
Q&A for Comirnaty (COVID-19 Vaccine mRNA)
12/7/2021
COVID-19 Vaccine Safety Surveillance
12/6/2021
Complete List of Licensed Products and Establishments
12/6/2021
Complete List of Substantially Equivalent 510(k) Device Applications
12/6/2021
Complete List of Currently Approved Premarket Approvals (PMAs)
12/6/2021
Complete List of Currently Approved NDA and ANDA Application Submissions
12/6/2021
December 3, 2021 Approval Letter - HAVRI
12/2/2021
Important Information for Blood Establishments and Transfusion Services Regarding Bacterial Contamination of Platelets for Transfusion
12/01/2021
November 30, 2021 Approval Letter - PREHEVBRIO
11/29/2021
BK210574 - LIFECODES LSA Class II
11/29/2021
BK210573 - LIFECODES LSA Class I
11/29/2021
BK210572 - MATCH IT! Antibody
11/29/2021
November 17, 2021 Approval Letter - AUDENZ
11/24/2021
Principal Investigator – Viral Vaccines
11/23/2021
November 19, 2021 Approval Letter - Trumenba
Content current as of:
12/23/2021