Items related to biologics will be added to the top of the list as they are posted on the site.
4/29/2022
Regulatory Education for Industry (REdI) Annual Conference 2022
4/27/2022
April 25, 2022 Approval Letter - ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP - BA 125750
4/22/2022
Annual Patient Engagement & Regenerative Medicine Meeting 2022: An FDA CBER Workshop for Patient Advocates
4/21/2022
April 21, 2022 Approval Letter - HIZENTRA
4/20/2022
CBER Vacancy: Physician (Neurologist)
4/20/2022
April 19, 2022 Approval Letter - CANDIN
4/19/2022
CBER Vacancy: Staff Fellow/Visiting Associate – Blood Borne Pathogens
4/19/2022
User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act
4/19/2022
April 6, 2022 Untitled Letter - The Regenerative Stem Cell Institute
4/18/2022
Cellular, Tissue, and Gene Therapies Advisory Committee June 9-10, 2022 Meeting Announcement
4/14/2022
April 1, 2022 Clinical Review and Evaluation - YESCARTA
4/14/2022
April 1, 2022 Clinical Pharmacology Memo - YESCARTA
4/14/2022
April 1, 2022 Statistical Reviewer - YESCARTA
4/11/2022
Clinical Investigator Status (Biologics)
4/7/2022
April 1, 2022 Approval Letter - YESCARTA
4/7/2022
Fast Track Designation Request Performance
4/5/2022
Q&A for Spikevax (COVID-19 Vaccine mRNA)
4/5/2022
Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year
4/5/2022
CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals
4/5/2022
CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year
4/4/2022
April 1, 2022 Approval Letter - Octagam 5% and 10%,
4/4/2022
April 1, 2022 Approval Letter - CINRYZE
4/1/2022
Complete List of Licensed Products and Establishments
4/1/2022
Complete List of Substantially Equivalent 510(k) Device Applications
4/1/2022
Complete List of Currently Approved Premarket Approvals (PMAs)
4/1/2022
Complete List of Currently Approved NDA and ANDA Application Submissions
3/31/2022
Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry
3/30/2022
Slides for The Critical Role of Patients in Advancing Gene Therapy Treatments for Rare Diseases
3/30/2022
Transcript for The Critical Role of Patients in Advancing Gene Therapy Treatments for Rare Diseases
3/28/2022
BK200540 - Precise Cell Concentration System
3/24/2022
BK220674 - MicroAire LipoFilter System
3/22/2022
An Acceptable Circular of Information for the Use of Human Blood and Blood Components; Guidance for Industry
3/21/2022
Vaccines and Related Biological Products Advisory Committee Meeting April 6, 2022 Announcement
Content current as of:
04/29/2022