Items related to biologics will be added to the top of the list as they are posted on the site.
12/16/2022
December 16, 2022 Approval Letter - ADSTILADRIN
12/16/2022
BK220769 - IH-Ab ID
12/15/2022
Assessing Genetic Heterogeneity in the Context of Genome Editing Off-Targets in Gene Therapy Products - Updated
12/15/2022
Tissue Reference Group - Updated
12/14/2022
Assessing Genetic Heterogeneity in the Context of Genome Editing Off-Targets in Gene Therapy Products - Updated
12/14/2022
BK220738 - DG Reader Net
12/13/2022
December 12, 2022 Approval Letter - VAXCHORA
12/12/2022
November 30, 2022 Summary Basis for Regulatory Action - REBYOTA
12/9/2022
eSubmitter Application History
12/8/2022
December 7, 2022 Approval Letter - DG Gel 8 ABO/Rh (2D)
12/8/2022
Drug Products Labeled as Homeopathic; Guidance for FDA Staff and Industry
12/8/2022
Assessing Genetic Heterogeneity in the Context of Genome Editing Off-Targets in Gene Therapy Products - Updated
12/8/2022
Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff
12/7/2022
2022 Center for Biologics Evaluation and Research (CBER) Science Symposium - Updated
12/7/2022
Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry
12/6/2022
CBER Vacancy: Staff Fellow/Visiting Associate – Biologist
12/5/2022
Clinical Review Memo of Labeling Supplement – SEVENFACT
12/01/2022
FDA Clinical Investigator Training Course (CITC) 2022
12/01/2022
BR220737 De Novo Classification Order
11/30/2022
November 30, 2022 Approval Letter - REBYOTA
11/28/2022
November 23, 2022 Approval Letter - KINRIX
11/28/2022
Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Guidance for Industry
11/25/2022
November 23, 2022 Approval Letter - INFANRIX
11/25/2022
November 23, 2022 Approval Letter - BOOSTRIX
11/25/2022
Information for Practitioners - FDA’s Regulatory Oversight of Regenerative Medicine Products - Updated
11/25/2022
FDA CBER OTAT Patient-Focused Drug Development Listening Meeting — Patient Perspectives on Gene Therapy Products - Updated
11/23/2022
November 22, 2022 Approval Letter - SEVENFACT
11/23/2022
Assessing Genetic Heterogeneity in the Context of Genome Editing Off-Targets in Gene Therapy Products
11/22/2022
November 22, 2022 Approval Letter - HEMGENIX
11/18/2022
November 17, 2022 Approval Letter - IXINITY
11/17/2022
OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls Transcript
11/16/2022
Principal Investigator - Interdisciplinary Scientist
11/16/2022
2022 Biological License Application Supplement Noteworthy Approvals
11/16/2022
2022 Biological Device Application Approvals
11/14/2022
SOPP 8405.1: Procedures for Resubmissions to an Application or Supplement
11/14/2022
SOPP 8403: Issuance, Reissuance, and Voluntary Revocation of Biological Products Licenses
11/10/2022
Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Guidance for Industry and Food and Drug Administration Staff
Content current as of:
12/16/2022
