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  1. News & Events (Biologics)

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.

1/18/2022 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1/6/2022 CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year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

 



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