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
