jueves, 5 de marzo de 2020

What’s New for Biologics | FDA

What’s New for Biologics | FDA

Posted: 3/3/2020






3/3/2020Complete List of Licensed Products and Establishments
3/3/2020Complete List of Substantially Equivalent 510(k) Device Applications
3/3/2020Complete List of Currently Approved Premarket Approvals (PMAs)
3/3/2020Complete List of Currently Approved NDA and ANDA Application Submissions
3/2/2020Statistical Review - FLUAD QUADRIVALENT
3/2/2020February 20, 2020 Clinical Review - FLUAD QUADRIVALENT
2/27/2020February 26, 2020 Approval Letter - ODACTRA
2/25/2020Synonymous mutation increases in vitro production and activity of enzyme that reduces blood clotting
2/25/2020Determining susceptibility of influenza A viruses to first-line immune response by pulmonary surfactant protein D (SP-D)
2/25/2020Universal test for assessing potency of inactivated poliovirus vaccines could facilitate their global production and availability
2/25/2020Allergenic Products Advisory Committee May 15, 2020 Meeting Announcement
2/21/2020February 21, 2020 Approval Letter - FLUAD QUADRIVALENT
2/21/2020February 20, 2020 Approval Letter - Gardasil 9
2/21/2020Final Agenda - Facilitating End-to-End Development of Individualized Therapeutics
2/21/2020February 20, 2020 Approval Letter - MENVEO
2/20/2020January 31, 2020 Summary Basis for Regulatory Action - AUDENZ
2/19/2020January 31, 2020 Summary Basis for Regulatory Action - PALFORZIA
2/19/20202020 Biological Device Application Approvals
2/19/20202020 Biological License Application Supplement Noteworthy Approvals
2/19/20202020 Biological License Application Approvals
2/14/2020Direct Recall Classification Program
2/14/2020Electronic Submission of Biological Product Deviation Reports (eBPDR)
2/14/2020Biological Product Deviations
2/14/2020General Instructions for Completing the Biological Product Deviation Report (BPDR) - Form FDA 3486
2/14/2020Instructions for Using the eBPDR System
2/14/2020Important Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the 2019 Novel Coronavirus Outbreak
2/14/2020February 13, 2020 Approval Letter - VAXCHORA
2/14/2020Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020
2/13/2020BK190317 - PurePRP SupraPhysiologic Concentrating System
2/13/2020February 10, 2020 Untitled Letter - RejuvaYou Medical Corporation
2/13/2020February 12, 2020 Approval Letter - Procleix Babesia Assay
2/13/2020Blood Products Advisory Committee April 2-3, 2020 Meeting Announcement
2/13/202023rd US-Japan Cellular and Gene Therapy Conference
2/11/2020eSubmitter Application History
2/11/2020BK190413 - CompoMat G5 Plus and CompoMaster Net G5 Plus System
2/10/2020January 17, 2020 Approval Letter - cobas MPX Test
2/7/2020February 7, 2020 Approval Letter - Fluzone Quadrivalent Southern Hemisphere
2/7/2020February 6, 2020 Approval Letter - FluLaval
2/6/2020CBER Vacancy: Staff Fellow/Visiting Associate – Vascular Biology
2/5/2020Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II); Guidance for Industry
2/4/2020Important Information for Blood Establishments Regarding the Novel Coronavirus Outbreak

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