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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.

10/21/2022 FDA CBER OTAT Patient-Focused Drug Development Listening Meeting — Patient Perspectives on Gene Therapy Products
10/21/2022 Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry
10/19/2022 2022 Biological Device Application Approvals
10/19/2022 2022 Biological License Application Approvals
10/19/2022 2022 Biological License Application Supplement Noteworthy Approvals
10/19/2022 Clinical Investigator Status (Biologics)
10/18/2022 Blood Products Advisory Committee December 8, 2022 Meeting Announcement
10/17/2022 Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA; Guidance for Industry
10/14/2022 October 14, 2022 Approval Letter - MENVEO
10/14/2022 eSubmitter Application History
10/14/2022 October 13, 2022 Approval Letter - ActHIB
10/13/2022 CBER Vacancy: Principal Investigator – Biologist/Research Pharmacologist
10/13/2022 Information for Practitioners - FDA’s Regulatory Oversight of Regenerative Medicine Products
10/11/2022 October 5, 2022 Untitled Letter - Regener-Eyes, LLC
10/11/2022 October 7, 2022 Approval Letter - BOOSTRIX
10/11/2022 Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year
10/11/2022 CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals
10/11/2022 CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year
10/5/2022 Summary Basis for Regulatory Action - SKYSONA
10/3/2022 September 30, 2022 Approval Letter - PREVNAR 20
10/3/2022 FDA CBER OTAT Patient-Focused Drug Development Listening Meeting — Patient Perspectives on Gene Therapy Products
10/3/2022 Complete List of Licensed Products and Establishments
10/3/2022 Complete List of Substantially Equivalent 510(k) Device Applications
10/3/2022 Complete List of Currently Approved Premarket Approvals (PMAs)
10/3/2022 Complete List of Currently Approved NDA and ANDA Application Submissions
9/30/2022 Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes
9/30/2022 Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes
9/30/2022 Biological Product Deviation Reporting -- Blood Product Codes
9/30/2022 BK220763 - LIFECODES LifeScreen XP
9/29/2022 Natural History Studies to Support Regenerative Medicine: A How-To Webinar
9/28/2022 Ethical Considerations for Clinical Investigations of Medical Products Involving Children; Draft Guidance for Industry, Sponsors, and IRBs
9/28/2022 Policy for Device Software Functions and Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff
9/28/2022 Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices; Guidance for Industry and Food and Drug Administration Staff
9/28/2022 Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff
9/26/2022 CBER Vacancy: Epidemiologist
9/23/2022 Electronic Submission Template for Medical Device 510(k) Submissions; Guidance for Industry and Food and Drug Administration Staff
9/22/2022 OTAT Learn
9/21/2022 FDA NanoDay Symposium 2022
9/20/2022 CBER Vacancy: Staff Fellow/Visiting Associate - Tick-Borne Diseases
9/19/2022 September 16, 2022 Approval Letter - SKYSONA


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