Items related to biologics will be added to the top of the list as they are posted on the site.
3/2/2022
February 28, 2022 Approval Letter - Standardized Short Ragweed 3/1/2022
Complete List of Licensed Products and Establishments 3/1/2022
Complete List of Substantially Equivalent 510(k) Device Applications 3/1/2022
Complete List of Currently Approved Premarket Approvals (PMAs) 3/1/2022
Complete List of Currently Approved NDA and ANDA Application Submissions 3/1/2022
February 28, 2022 Approval Letter - CARVYKTI 2/25/2022
February 23, 2022 Approval Letter - OraSure HIV-1 Oral Specimen Collection Device 2/24/2022
February 24, 2022 Approval Letter - Non-Standardized Allergenic Extracts 2/24/2022
BK210632 - Royal MAXX PRP Concentration System 2/18/2022
Approval History, Letters, Reviews, and Related Documents - SPIKEVAX 2/18/2022
February 17, 2022 Approval Letter - AFLURIA 2/16/2022
BK210591 - Platelet-Rich Plasma (PRP) Procedure Pack 2/16/2022
Cellular, Tissue, and Gene Therapies Advisory Committee March 10, 2022 Meeting Announcement 2/15/2022
February 14, 2022 Approval Letter - Fluzone Quadrivalent Southern Hemisphere 2/14/2022
International Engagements to Respond to Covid-19 Pandemic 2/10/2022
CBER Vacancy: Staff Fellow - Biologist 2/8/2022
Preguntas y respuestas sobre Spikevax (vacuna de ARNm contra el COVID-19) 2/8/2022
Preguntas y respuestas sobre Comirnaty (Vacuna de ARNm contra el COVID-19) 2/8/2022
Q&A for Comirnaty (COVID-19 Vaccine mRNA) 2/8/2022
OTAT Learn 2/7/2022
CBER-Regulated Products: Resolved Shortages 2/3/2022
January 30, 2022 Summary Basis for Regulatory Action - SPIKEVAX 2/3/2022
RegenMedEd Webinar: The Critical Role of Patients in Advancing Gene Therapy Treatments for Rare Diseases 2/2/2022
Q&A for Comirnaty (COVID-19 Vaccine mRNA) 2/2/2022
Q&A for Spikevax (COVID-19 Vaccine mRNA) 2/02/2022
Vaccines and Related Biological Products Advisory Committee February 15, 2022 Meeting Announcement
Content current as of:
03/02/2022
