Items related to biologics will be added to the top of the list as they are posted on the site.
4/12/2021
Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2021 4/8/2021
Annual Summary for Fiscal Year 2020 4/7/2021
eSubmitter Application History 4/6/2021
Patient Engagement & Regenerative Medicine: An FDA CBER Workshop for Patient Advocates 4/6/2021
CBER Vacancy: Staff Fellow/Visiting Associate: Cell Biology 4/5/2021
Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year 4/5/2021
CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals 4/5/2021
CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year 4/5/2021
March 23, 2021 Untitled Letter - Curex, Inc. 4/5/2021
CBER-Regulated Products: Resolved Shortages 4/2/2021
Complete List of Licensed Products and Establishments 4/2/2021
Complete List of Substantially Equivalent 510(k) Device Applications 4/2/2021
Complete List of Currently Approved Premarket Approvals (PMAs) 4/2/2021
Complete List of Currently Approved NDA and ANDA Application Submissions 3/31/2021
TRG Rapid Inquiry Program (TRIP) 3/30/2021
March 29, 2021 Untitled Letter - Neil P. Sheth, MD 3/27/2021
March 26, 2021 Approval Letter - ABECMA 3/25/2021
March 3, 2021 Approval Letter - IXINITY 3/25/2021
March 24, 2021 Approval Letter - SHINGRIX 3/24/2021
FDA Requires a Warning about Guillain-Barré Syndrome (GBS) be Included in the Prescribing Information for Shingrix 3/24/2021
March 22, 2021 Untitled Letter - Michael L. Levin, MD 3/22/2021
2021 Biological License Application Approvals 3/22/2021
2021 Biological License Application Supplement Noteworthy Approvals 3/22/2021
2021 Biological Device Application Approvals 3/22/2021
eSubmitter Application History 3/19/2021
CBER 2021-2025 Strategic Plan 3/16/2021
March 16, 2021 Approval Letter - ZOLGENSMA 3/12/2021
March 10, 2021 Untitled Letter - Reno Integrative Medical Center 3/12/2021
Clinical Review (STN: 125408/329) - Flucelvax Quadrivalent 3/12/2021
Statistical Review (STN: 125408/329) - Flucelvax Quadrivalent 3/12/2021
BK200549 - ORTHO Optix Reader 3/11/2021
March 10, 2021 Approval Letter - Anti-Human Globulin (BL 1034615114) and Blood Grouping Reagent (103756/5095 et al.) 3/11/2021
March 10, 2021 Approval Letter - 0.8% SELECTOGEN; 0.8% SURGISCREEN; 0.8% AFFIRMAGEN; 0.8% RESOLVE PANELS A, B, C; 0.8% POOLING SCREENING CELLS 3/9/2021
Tissue Establishment Registration 3/9/2021
eSubmitter Application History
Content current as of:
04/12/2021
