What’s New for Biologics

Latest News from the Center for Biologics Evaluation and Research at FDA

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

10/31/2022	Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HTP/Ps) - Small Entity Compliance Guide; Guidance for Industry
10/31/2022	Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care; Draft Guidance for Industry and Food and Drug Administration Staff
10/27/2022	Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions; Guidance for Industry and Food and Drug Administration Staff
10/26/2022	OTAT Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls
10/26/2022	BK220673 - Sterile Tube Welder (Model: STW6810-RFID)
10/26/2022	Assessing Genetic Heterogeneity in the Context of Genome Editing Off-Targets in Gene Therapy Products
10/26/2022	Center for Biologics Evaluation and Research
10/24/2022	October 21, 2022 Approval Letter - Pentacel
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10/11/2022	CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year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