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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.

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
9/19/2022 September 16, 2022 Approval Letter - ERVEBO
9/19/2022 Approval History, Letters, Reviews and Related Documents – ZYNTEGLO
9/15/2022 OTAT Learn
9/14/2022 2022 Biological License Application Approvals
9/14/2022 2022 Biological Device Application Approvals
9/14/2022 eSubmitter Application History
9/13/2022 Computer Software Assurance for Production and Quality System Software; Draft Guidance for Industry and Food and Drug Administration Staff
9/13/2022 CBER Vacancy: Principal Investigator – Biologist/Research Pharmacologist
9/12/2022 CBER Vacancy: Staff Fellow/Visiting Associate – Molecular Cell Biology
9/12/2022 September 9, 2022 Approval Letter - RAGWITEK
9/12/2022 September 9, 2022 Approval Letter - GRASTEK
9/9/2022 Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products; Draft Guidance for Industry
9/9/2022 Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products; Guidance for Industry
9/9/2022 BK220750 - st’rim, macro st'rim, mini st’rim and nano st’rim
9/8/2022 August 17, 2022 Summary Basis for Regulatory Action - ZYNTEGLO
9/6/2022 CBER Vacancy: Principal Investigator - Biomedical Engineering
9/2/2022 September 2, 2022 Approval Letter - JYNNEOS
9/1/2022 Complete List of Licensed Products and Establishments
9/1/2022 Complete List of Substantially Equivalent 510(k) Device Applications
9/1/2022 Complete List of Currently Approved Premarket Approvals (PMAs)
9/1/2022 Complete List of Currently Approved NDA and ANDA Application Submissions
9/1/2022 BK210658 - IMUGARD® WB PLT Platelet Pooling Set
8/31/2022 FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing: An Opportunity for DM/POC Stakeholder Engagement
8/29/2022 2022 Biological License Application Approvals
8/29/2022 2022 Biological License Application Supplement Noteworthy Approvals
8/29/2022 2022 Biological Device Application Approvals
8/29/2022 August 25, 2022 Approval Letter - COMIRNATY
8/29/2022 Important Information for Human Cell, Tissue, and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Monkeypox Virus and HCT/P Donation
8/22/2022 Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to Monkeypox Virus
8/22/2022 CBER Vacancy: Staff Fellow/Visiting Associate - Pharmacology/Toxicology Reviewer
8/19/2022 2022 Center for Biologics Evaluation and Research (CBER) Science Symposium
8/18/2022 Key Facts About Vaccines to Prevent Monkeypox Disease
8/17/2022 August 17, 2022 Approval Letter - ZYNTEGLO
8/17/2022 Vaccines and Related Biological Products Advisory Committee October 6, 2022 Meeting Announcement
8/15/2022 PREA Non-Compliance Letters


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