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.

9/15/2022	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9/13/2022	Computer Software Assurance for Production and Quality System Software; Draft Guidance for Industry and Food and Drug Administration Staff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Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products; Draft Guidance for Industry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