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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.

2/18/2022 Approval History, Letters, Reviews, and Related Documents - SPIKEVAX
2/18/2022 February 17, 2022 Approval Letter - AFLURIA
2/16/2022 BK210591 - Platelet-Rich Plasma (PRP) Procedure Pack
2/16/2022 Cellular, Tissue, and Gene Therapies Advisory Committee March 10, 2022 Meeting Announcement
2/15/2022 February 14, 2022 Approval Letter - Fluzone Quadrivalent Southern Hemisphere
2/14/2022 International Engagements to Respond to Covid-19 Pandemic
2/10/2022 CBER Vacancy: Staff Fellow - Biologist
2/8/2022 Preguntas y respuestas sobre Spikevax (vacuna de ARNm contra el COVID-19)
2/8/2022 Preguntas y respuestas sobre Comirnaty (Vacuna de ARNm contra el COVID-19)
2/8/2022 Q&A for Comirnaty (COVID-19 Vaccine mRNA)
2/8/2022 OTAT Learn
2/7/2022 CBER-Regulated Products: Resolved Shortages
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

 



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