12/2/2021 |
Important Information for Blood Establishments and Transfusion Services Regarding Bacterial Contamination of Platelets for Transfusion |
12/01/2021 |
November 30, 2021 Approval Letter - PREHEVBRIO |
11/29/2021 |
BK210574 - LIFECODES LSA Class II |
11/29/2021 |
BK210573 - LIFECODES LSA Class I |
11/29/2021 |
BK210572 - MATCH IT! Antibody |
11/29/2021 |
November 17, 2021 Approval Letter - AUDENZ |
11/24/2021 |
Principal Investigator – Viral Vaccines |
11/23/2021 |
November 19, 2021 Approval Letter - Trumenba |
11/17/2021 |
October 1, 2021 Clinical Review and Evaluation - TECARTUS |
11/17/2021 |
Pharmacology/Toxicology Review - TECARTUS |
11/17/2021 |
Statistical Review - TECARTUS |
11/17/2021 |
Clinical Review - CUTAQUIG |
11/17/2021 |
Statistical Review - CUTAQUIG |
11/17/2021 |
CBER-Regulated Products: Current Shortages |
11/17/2021 |
2021 Biological License Application Approvals |
11/17/2021 |
2021 Biological Device Application Approvals |
11/17/2021 |
2021 Biological License Application Supplement Noteworthy Approvals |
11/16/2021 |
eSubmitter Application History |
11/12/2021 |
CBER-Regulated Products: Resolved Shortages |
11/10/2021 |
November 5, 2021 Untitled Letter - NYC Regenerative Medicine, Inc. dba Colts Neck Stem Cells and Regenerative Medicine |
11/10/2021 |
November 8, 2021 Summary Basis for Regulatory Action - Comirnaty |
11/8/2021 |
eSubmitter Application History |
11/8/2021 |
CBER Vacancy: Principal Investigator - Pathogen Reduction of Whole Blood: Hematology and Coagulation Biology |
11/8/2021 |
CBER Vacancy: Principal Investigator – Pathogen Reduction of Whole Blood: Microbiology and Infectious Diseases |
11/5/2021 |
CBER Vacancy: Staff Fellow - Biologist/Microbiologist |
11/4/2021 |
Regenerative Medicine 101 Webinar: Information for Patients, Caregivers & Advocates |
11/3/2021 |
Influenza Vaccine for the 2021-2022 Season |
11/3/2021 |
Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers; Guidance for Industry |
11/2/2021 |
October 27, 2021 Approval Letter - KOVALTRY |
11/2/2021 |
Complete List of Licensed Products and Establishments |
11/2/2021 |
Complete List of Substantially Equivalent 510(k) Device Applications |
11/2/2021 |
Complete List of Currently Approved Premarket Approvals (PMAs) |
11/2/2021 |
Complete List of Currently Approved NDA and ANDA Application Submissions |
11/2/2021 |
BK210621 - rControl RBC and PLT |
11/1/2021 |
October 29, 2021 Approval Letter - AUDENZ |
10/29/2021 |
October 8, 2021 Summary Basis for Regulatory Action - RETHYMIC |
10/29/2021 |
October 27, 2021 Untitled Letter - Riverside Biologics |
10/28/2021 |
October 27, 2021 Approval Letter - PNEUMOVAX 23 |
10/28/2021 |
Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 |
10/28/2021 |
October 27, 2021 Approval Letter - MenQuadfi |
10/28/2021 |
Influenza Vaccine for the 2021-2022 Season |
10/27/2021 |
October 22, 2021 Approval Letter - CUTAQUIG |
10/26/2021 |
October 22, 2021 Approval Letter - ZOLGENSMA |
10/25/2021 |
2021 Biological License Application Approvals |
10/25/2021 |
2021 Biological Device Application Approvals |
10/22/2021 |
Clinical Review (125408/351) - Flucelvax Quadrivalent |
10/22/2021 |
Statistical Review (125408/351) - Flucelvax Quadrivalent |
10/22/2021 |
PREA Non-Compliance Letters |
10/21/2021 |
Staff Fellow – Bioinformatics Reviewer |
10/21/2021 |
Influenza Vaccine for the 2021-2022 Season |
10/19/2021 |
PREA Non-Compliance Letters |