What’s New for Biologics

Latest news from the Center for Biologics and Evaluation at FDA.

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

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1/6/2022	CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year
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