Data as of June 30, 2019; Posted: 7/5/2019
Posted: 7/5/2019
Posted: 7/5/2019
Updated as of 6/30/2019; Posted: 7/5/2019
Updated as of 6/30/2019; Posted: 7/5/2019
Updated as of 6/30/2019; Posted: 7/5/2019
Updated as of 6/30/2019; Posted: 7/5/2019
7/5/2019 | Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year Data as of June 30, 2019 |
7/5/2019 | July 3, 2019 Approval Letter - XEMBIFY |
7/5/2019 | Influenza Vaccine for the 2019-2020 Season |
7/5/2019 | Complete List of Currently Approved NDA and ANDA Application Submissions Updated as of 6/30/2019 |
7/5/2019 | Complete List of Currently Approved Premarket Applications (PMAs) Updated as of 6/30/2019 |
7/5/2019 | Complete List of Substantially Equivalent 510(k) Device Applications Updated as of 6/30/2019 |
7/5/2019 | Complete List of Licensed Products and Establishments Updated as of 6/30/2019 |
7/3/2019 | July 2, 2019 Approval Letter - Flucelvax |
7/3/2019 | July 2, 2019 Approval Letter - Fluad |
7/3/2019 | July 2, 2019 Approval Letter - Afluria |
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