Items related to biologics will be added to the top of the list as they are posted on the site.
2/3/2022
January 30, 2022 Summary Basis for Regulatory Action - SPIKEVAX
2/3/2022
RegenMedEd Webinar: The Critical Role of Patients in Advancing Gene Therapy Treatments for Rare Diseases
2/2/2022
Q&A for Comirnaty (COVID-19 Vaccine mRNA)
2/2/2022
Q&A for Spikevax (COVID-19 Vaccine mRNA)
2/02/2022
Vaccines and Related Biological Products Advisory Committee February 15, 2022 Meeting Announcement
2/1/2022
Complete List of Licensed Products and Establishments
2/1/2022
Complete List of Substantially Equivalent 510(k) Device Applications
2/1/2022
Complete List of Currently Approved Premarket Approvals (PMAs)
2/1/2022
Complete List of Currently Approved NDA and ANDA Application Submissions
2/1/2022
BK210652 - BD Stem Cell Enumeration Kit
1/31/2022
January 24, 2022 Clinical Memorandum - YESCARTA
1/31/2022
January 28, 2022 Approval Letter - cobas TaqScreen MPX Test, version 2.0
1/31/2022
January 31, 2022 Approval Letter - SPIKEVAX
1/31/2022
January 28, 2022 Approval Letter - VONVENDI
1/31/2022
January 28, 2022 Approval Letter - Alere Determine HIV-1/2 Ag/Ab Combo
1/28/2022
Vaccines and Related Biological Products Advisory Committee March 3, 2022 Meeting Announcement
1/27/2022
January 25, 2022 Approval Letter - YESCARTA
1/26/2022
Premarket Approval (PMA) for CBER-Regulated Products
1/24/2022
Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2022
1/24/2022
BK210649 - BD Vacutainer ACD A Blood Collection Tube; BD Vacutainer ACD B Blood Collection Tube
1/20/2022
Patient Engagement & Regenerative Medicine: An FDA CBER Workshop for Patient Advocates
1/18/2022
Frequently Asked Questions (FAQs): Electronic Submissions Program for CBER-Regulated Products
1/18/2022
Premarket Notification 510(k) Process for CBER-Regulated Products
1/14/2022
Clinical Investigator Status (Biologics)
1/14/2022
2021 Biological Device Application Approvals
1/13/2022
CBER Vacancy: Staff Fellow - Pharmacology/Toxicology Reviewer
1/11/2022
Exceptions and Alternative Procedures Approved Under 21 CFR 640.120(a)
1/11/2022
Updated Information for Blood Establishments Regarding the COVID-19 Pandemic and Blood Donation
1/10/2022
Recommendations for Investigational COVID-19 Convalescent Plasma
1/10/2022
eSubmitter Application History
1/7/2022
Investigational COVID-19 Convalescent Plasma; Guidance for Industry
1/7/2022
January 6, 2022 Approval Letter - BEXSERO
1/6/2022
Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year
1/6/2022
CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals
1/6/2022
CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year
Content current as of:
02/03/2022