What’s New for Biologics | FDA

What’s New for Biologics | FDA

Posted: 10/02/2020

• Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes
• Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes
• Biological Product Deviation Reporting -- Blood Product Codes
• October 1, 2020 Approval Order - DPP HIV-Syphilis System
• Complete List of Licensed Products and Establishments
• Complete List of Substantially Equivalent 510(k) Device Applications
• Complete List of Currently Approved Premarket Approvals (PMAs)
• Complete List of Currently Approved NDA and ANDA Application Submissions

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
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