Items related to biologics will be added to the top of the list as they are posted on the site.
2/5/2020
Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II); Guidance for Industry
2/4/2020
Complete List of Licensed Products and Establishments
2/4/2020
Complete List of Substantially Equivalent 510(k) Device Applications
2/4/2020
Complete List of Currently Approved Premarket Approvals (PMAs)
2/4/2020
Complete List of Currently Approved NDA and ANDA Application Submissions
2/4/2020
Important Information for Blood Establishments Regarding the Novel Coronavirus Outbreak
2/3/2020
Facilitating End-to-End Development of Individualized Therapeutics
1/31/2020
January 31, 2020 Approval Letter - PALFORZIA
1/31/2020
January 31, 2020 Approval Letter - AUDENZ
1/31/2020
BK190429 - HemoMix 4 (Basic version) and HemoMix 4 (Internal optional RFID installed version)
1/30/2020
Clinical Review - Agriflu
1/30/2020
Statistical Review - Agriflu
1/30/2020
Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry
1/29/2020
January 28, 2020 Approval Letter - Agriflu
1/28/2020
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry
1/28/2020
Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Guidance for Industry
1/28/2020
Human Gene Therapy for Retinal Disorders; Guidance for Industry
1/28/2020
Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry
1/28/2020
Human Gene Therapy for Rare Diseases; Guidance for Industry
1/28/2020
Human Gene Therapy for Hemophilia; Guidance for Industry
1/28/2020
Long Term Follow-Up After Administration of Human Gene Therapy Products; Guidance for Industry
1/24/2020
January 22, 2020 Approval Letter - PROCLEIX WNV ASSAY
1/24/2020
January 23, 2020 Approval Letter - Afluria and Afluria Quadrivalent
1/23/2020
January 22, 2020 Approval Letter - DENGVAXIA
1/22/2020
BK190439 - MATCH IT! DNA (version 1.3)
1/22/2020
2019 Biological Device Application Approvals
1/22/2020
2019 Biological License Application Supplement Noteworthy Approvals
1/22/2020
2019 Biological License Application Approvals
1/17/2020
Vaccines and Related Biological Products Advisory Committee March 4, 2020 Meeting Announcement
1/15/2020
December 19, 2019 Summary Basis for Regulatory Action - ERVEBO
1/13/2020
CBER Vacancy: Physician, Division of Epidemiology (DE)
1/10/2020
Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies – Transcript
1/10/2020
January 8, 2020 Approval Letter - GRASTEK
1/9/2020
CBER-Regulated Products: Current Shortages
1/7/2020
CBER Vacancy: Senior Staff Fellow – Allergic Diseases
Content current as of:
02/05/2020