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CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year 4/4/2022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
