What’s New for Biologics | FDA

What’s New for Biologics | FDA

Posted: 10/15/2020

• Influenza Vaccine for the 2020-2021 Season
• Testing for Biotin Interference in In Vitro Diagnostic Devices; Guidance for Industry

10/15/2020	Influenza Vaccine for the 2020-2021 Season
10/15/2020	Testing for Biotin Interference in In Vitro Diagnostic Devices; Guidance for Industry
10/13/2020	Clinical Review - HAEGARDA
10/13/2020	Statistical Review -  HAEGARDA
10/8/2020	Influenza Vaccine for the 2020-2021 Season
10/7/2020	Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation- Speaker
10/7/2020	October 1, 2020 Untitled Letter - Optimal Health Stem Cell and Wellness Institute dba OHSTEMCELL
10/7/2020	Summary of Safety and Effectiveness -DPP HIV-Syphilis System
10/7/2020	Influenza Vaccine for the 2020-2021 Season
10/7/2020	BK200498 - NexSys PCS Plasma Collection System with Persona Technology
10/6/2020	Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry
10/6/2020	eSubmitter Application History
10/6/2020	FDA Briefing Document for Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting
10/5/2020	September 24, 2020 Approval Letter - HAEGARDA
10/5/2020	Regenerative Medicine Advanced Therapy Designation
10/2/2020	Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes
10/2/2020	Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes
10/2/2020	Biological Product Deviation Reporting -- Blood Product Codes
10/2/2020	October 1, 2020 Approval Order - DPP HIV-Syphilis System
10/2/2020	Complete List of Licensed Products and Establishments
10/2/2020	Complete List of Substantially Equivalent 510(k) Device Applications
10/2/2020	Complete List of Currently Approved Premarket Approvals (PMAs)
10/2/2020	Complete List of Currently Approved NDA and ANDA Application Submissions
10/1/2020	BK200488 - ASI Automated RPR test for Syphilis for use on the ASI Evolution
10/1/2020	Influenza Vaccine for the 2020-2021 Season
9/30/2020	Considerations for the Use of Real-World Evidence to Assess the Effectiveness of Preventive Vaccines Recordings
9/30/2020	September 25, 2020 Approval Letter - IXINITY
9/29/2020	September 28, 2020 Approval Letter - ALBAcyte
9/28/2020	September 25, 2020 Approval Letter - VAXELIS
9/25/2020	September 25, 2020 Approval Letter - PNEUMOVAX 23
9/24/2020	Influenza Vaccine for the 2020-2021 Season
9/23/2020	2020 Biological License Application Supplement Noteworthy Approvals
9/23/2020	2020 Biological Device Application Approvals
9/21/2020	Countering Bioterrorism and Emerging Infectious Diseases
9/17/2020	Influenza Vaccine for the 2020-2021 Season
9/17/2020	September 15, 2020 Approval Letter - ProQuad
9/16/2020	September 15, 2020 Approval Letter - VARIVAX
9/10/2020	Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020
9/10/2020	September 9, 2020 Approval Letter - ODACTRA
9/10/2020	Influenza Vaccine for the 2020-2021 Season
9/8/2020	September 3, 2020 Untitled Letter - Laguna Beach Aesthetics, Cosmetic Dermatology and Laser Center, PC
9/8/2020	eSubmitter Application History