Items related to biologics will be added to the top of the list as they are posted on the site.
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
8/12/2022
User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act
8/12/2022
Information for Blood Establishments Regarding the Monkeypox Virus and Blood Donation
8/11/2022
August 10, 2022 Approval Letter - Octagam 5%
8/10/2022
August 5, 2022 Approval Letter - ZOLGENSMA
8/10/2022
Vaccines and Related Biological Products Advisory Committee September 22, 2022 Meeting Announcement
8/4/2022
OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls
Content current as of:
09/02/2022