What’s New for Biologics

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9/13/2022	Computer Software Assurance for Production and Quality System Software; Draft Guidance for Industry and Food and Drug Administration Staff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Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products; Draft Guidance for Industry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