Items related to biologics will be added to the top of the list as they are posted on the site.
3/22/2022
An Acceptable Circular of Information for the Use of Human Blood and Blood Components; Guidance for Industry 3/21/2022
Vaccines and Related Biological Products Advisory Committee Meeting April 6, 2022 Announcement 3/18/2022
February 28, 2022 Summary Basis for Regulatory Action - CARVYKTI 3/16/2022
2022 Biological License Application Approvals 3/16/2022
2022 Biological Device Application Approvals 3/16/2022
SOPP 8795: Posting and Announcement of Premarket Approval Application and Humanitarian Device Exemption Approvals and Denials 3/16/2022
SOPP 8704: Managing MDUFA User Fee Payments and Billing Activities 3/16/2022
SOPP 8507:Procedures for Responding to an Illegitimate Product Notification and Request for Termination of Notification 3/15/2022
BK210635 - Rika Plasma Donation System; Rika Plasma Separation Set; Rika Plasma Bottle 3/15/2022
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products; Draft Guidance for Industry 3/15/2022
Human Gene Therapy Products Incorporating Human Genome Editing; Draft Guidance for Industry 3/9/2022
eSubmitter Application History 3/8/2022
CBER Vacancy: Bioinformatics Reviewer 3/7/2022
BK210625 - IH-500 3/4/2022
February 28, 2022 Approval Letter - Blood Grouping Reagent (BL 125096-125097, 125202-125206, 125208, 125529, 125532-125533) 3/3/2022
Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions 3/3/2022
February 28, 2022 Approval Letter - Blood Grouping Reagent (STN# 125098 & 125208) 3/3/2022
CBER Expanded Access Submission Receipt Reports 3/2/2022
February 28, 2022 Approval Letter - Standardized Short Ragweed 3/1/2022
Complete List of Licensed Products and Establishments 3/1/2022
Complete List of Substantially Equivalent 510(k) Device Applications 3/1/2022
Complete List of Currently Approved Premarket Approvals (PMAs) 3/1/2022
Complete List of Currently Approved NDA and ANDA Application Submissions 3/1/2022
February 28, 2022 Approval Letter - CARVYKTI 2/25/2022
February 23, 2022 Approval Letter - OraSure HIV-1 Oral Specimen Collection Device 2/24/2022
February 24, 2022 Approval Letter - Non-Standardized Allergenic Extracts 2/24/2022
BK210632 - Royal MAXX PRP Concentration System 2/18/2022
Approval History, Letters, Reviews, and Related Documents - SPIKEVAX 2/18/2022
February 17, 2022 Approval Letter - AFLURIA
Content current as of:
03/22/2022
