What’s New for Biologics | FDA

What’s New for Biologics | FDA

Posted: 9/30/2020

• Considerations for the Use of Real-World Evidence to Assess the Effectiveness of Preventive Vaccines Recordings
• September 25, 2020 Approval Letter - IXINITY

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
9/3/2020	Influenza Vaccine for the 2020-2021 Season
9/2/2020	Recommendations for Investigational COVID-19 Convalescent Plasma
9/2/2020	Investigational COVID-19 Convalescent Plasma; Guidance for Industry
9/2/2020	Complete List of Licensed Products and Establishments
9/2/2020	Complete List of Substantially Equivalent 510(k) Device Applications
9/2/2020	Complete List of Currently Approved Premarket Approvals (PMAs)
9/2/2020	Complete List of Currently Approved NDA and ANDA Application Submissions
8/27/2020	Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Announcement
8/27/2020	August 27, 2020 Approval Letter - Afluria
8/27/2020	Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry
8/26/2020	Influenza Vaccine for the 2020-2021 Season
8/26/2020	Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Guidance for Industry
8/23/2020	Coronavirus (COVID-19) | CBER-Regulated Biologics
8/23/2020	Recommendations for Investigational COVID-19 Convalescent Plasma