martes, 6 de octubre de 2020

What’s New for Biologics | FDA

What’s New for Biologics | FDA

Posted: 10/05/2020
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10/06/2020FDA Briefing Document for Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting
10/5/2020September 24, 2020 Approval Letter - HAEGARDA
10/5/2020Regenerative Medicine Advanced Therapy Designation
10/2/2020Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes
10/2/2020Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes
10/2/2020Biological Product Deviation Reporting -- Blood Product Codes
10/2/2020October 1, 2020 Approval Order - DPP HIV-Syphilis System
10/2/2020Complete List of Licensed Products and Establishments
10/2/2020Complete List of Substantially Equivalent 510(k) Device Applications
10/2/2020Complete List of Currently Approved Premarket Approvals (PMAs)
10/2/2020Complete List of Currently Approved NDA and ANDA Application Submissions
10/1/2020BK200488 - ASI Automated RPR test for Syphilis for use on the ASI Evolution
10/1/2020Influenza Vaccine for the 2020-2021 Season
9/30/2020Considerations for the Use of Real-World Evidence to Assess the Effectiveness of Preventive Vaccines Recordings
9/30/2020September 25, 2020 Approval Letter - IXINITY
9/29/2020September 28, 2020 Approval Letter - ALBAcyte
9/28/2020September 25, 2020 Approval Letter - VAXELIS
9/25/2020September 25, 2020 Approval Letter - PNEUMOVAX 23
9/24/2020Influenza Vaccine for the 2020-2021 Season
9/23/20202020 Biological License Application Supplement Noteworthy Approvals
9/23/20202020 Biological Device Application Approvals
9/21/2020Countering Bioterrorism and Emerging Infectious Diseases
9/17/2020Influenza Vaccine for the 2020-2021 Season
9/17/2020September 15, 2020 Approval Letter - ProQuad
9/16/2020September 15, 2020 Approval Letter - VARIVAX
9/10/2020Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020
9/10/2020September 9, 2020 Approval Letter - ODACTRA
9/10/2020Influenza Vaccine for the 2020-2021 Season
9/8/2020September 3, 2020 Untitled Letter - Laguna Beach Aesthetics, Cosmetic Dermatology and Laser Center, PC
9/8/2020eSubmitter Application History

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