What’s New for Biologics

Items related to biologics will be added to the top of the list as they are posted on the site.

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1/6/2022	CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year
1/3/2022	Complete List of Licensed Products and Establishments
1/3/2022	Complete List of Substantially Equivalent 510(k) Device Applications
1/3/2022	Complete List of Currently Approved Premarket Approvals (PMAs)
1/3/2022	Complete List of Currently Approved NDA and ANDA Application Submissions
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