Items related to biologics will be added to the top of the list as they are posted on the site.
6/3/2024
BK230958 - HemDonER 1.0.1
6/3/2024
Complete List of Licensed Products and Establishments
Update
6/3/2024
Complete List of Substantially Equivalent 510(k) Device Applications
Update
6/3/2024
Complete List of Currently Approved Premarket Approvals (PMAs)
Update
6/3/2024
Complete List of Currently Approved NDA and ANDA Application Submissions
Update
5/31/2024
May 31, 2024 Approval Letter - MRESVIA
5/31/2024
Platform Technology Designation Program for Drug Development; Draft Guidance for Industry
5/31/2024
May 28, 2024 564A expiry extension letter - Jynneos
5/31/2024
May 30, 2024 Approval Letter - BREYANZI
5/30/2024
CBER Title 21 Vacancy Announcement - Mathematical Statistician, Band D, Office of Biostatistics and Pharmacovigilance (OBPV), Division of Biostatistics (DB)
5/22/2024
Vaccines and Related Biological Products Advisory Committee June 5, 2024 Meeting Announcement
5/22/2024
CBER Title 21 Vacancy Announcement – Division Director, AD-0602-Band F, Office of Blood Research and Review (OBRR), Division of Blood Components and Devices (DBCD)
5/22/2024
CBER Title 21 Vacancy Announcement – Interdisciplinary Scientist (Team Lead), Band D, Office of Vaccines Research and Review (OVRR), Division of Review Management and Regulatory Review (DRMRR)
5/21/2024
Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Communicable Disease Agent or Disease
5/20/2024
BK231013 - LipoGrafter Kit
5/20/2024
April 5, 2024 Clinical Review - CARVYKTI
5/17/2024
April 25, 2024 Summary Basis for Regulatory Action - BEQVEZ
5/17/2024
May 7, 2024 Statistical Review - ALTUVIIIO
5/17/2024
May 7, 2024 Clinical Review Memo- ALTUVIIIO
5/16/2024
May 15, 2024 Approval Letter - BREYANZI
5/16/2024
Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products; Draft Guidance for Industry
Updated: May 15, 2024
5/16/2024
Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry
Updated: May 15, 2024
5/13/2024
Annual Summary for Fiscal Year 2023
5/10/2024
May 10, 2024 Approval Letter - ALTUVIIIO
5/10/2024
May 9, 2024 Approval Letter - RabAvert
5/10/2024
Remanufacturing of Medical Devices; Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff
5/9/2024
May 7, 2024 Untitled Letter - Exocel Bio, Inc.
5/8/2024
REMS Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance for Industry
5/8/2024
eSubmitter Application History
Updated
5/7/2024
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Inspection Information
Updated
Content current as of:
06/03/2024