What’s New for Biologics | FDA

What’s New for Biologics | FDA

Posted: 8/19/2020

• eSubmitter Application History
• Recommendations for Investigational COVID-19 Convalescent Plasma

8/20/2020	2020 Biological Device Application Approvals
8/20/2020	2020 Biological License Application Approvals
8/20/2020	Clinical Review - XYNTHA
8/20/2020	Statistical Review - XYNTHA
8/19/2020	Influenza Vaccine for the 2020-2021 Season
8/19/2020	eSubmitter Application History
8/19/2020	Recommendations for Investigational COVID-19 Convalescent Plasma
8/18/2020	Updated Workshop Agenda - Use of Real World Evidence to Support Effectiveness of Preventive Vaccines
8/17/2020	August 13, 2020 Approval Letter - XYNTHA
8/17/2020	August 14, 2020 Approval Letter - RotaTeq
8/14/2020	Novel Methods to Detect Malaria Biomarkers for Evaluation of Vaccine Safety and Efficacy
8/14/2020	Immunogenicity of Gene Therapy Products
8/14/2020	August 12, 2020 Summary of the Safety and Effectiveness - cobas HIV-1/HIV-2 Qualitative
8/13/2020	August 12, 2020 Approval Order - cobas HIV-1/HIV-2 Qualitative
8/13/2020	August 11, 2020 Untitled Letter - East West Health Solutions, Inc.
8/12/2020	July 23, 2020 Summary Basis for Regulatory Action - TECARTUS
8/12/2020	Influenza Vaccine for the 2020-2021 Season
8/12/2020	CBER-Regulated Products: Resolved Shortages
8/11/2020	Vaccines and Related Biological Products Advisory Committee October 2, 2020 Meeting Announcement
8/7/2020	BK200449 – Healeon Duet
8/5/2020	Workshop Agenda - Use of Real World Evidence to Support Effectiveness of Preventive Vaccines
8/5/2020	Influenza Vaccine for the 2020-2021 Season
8/4/2020	Complete List of Licensed Products and Establishments
8/4/2020	Complete List of Substantially Equivalent 510(k) Device Applications
8/4/2020	Complete List of Currently Approved Premarket Approvals (PMAs)
8/4/2020	Complete List of Currently Approved NDA and ANDA Application Submissions
8/3/2020	BK200491 - iWeBB electronic Laboratory Information System (iWeBB-eLIS) v1.0.0
8/3/2020	Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
8/3/2020	MedWatch to Manufacturer Program
7/31/2020	CBER-Regulated Products: Resolved Shortages
7/31/2020	CBER-Regulated Products: Current Shortages
7/28/2020	Influenza neuraminidase antigenicity and efficacy in vaccines
7/28/2020	July 28, 2020 Approval Letter - MENVEO
7/28/2020	Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
7/28/2020	User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act
7/28/2020	July 22, 2020 Untitled Letter - American Medical Aesthetics and Regenerative Medicine Inc.
7/24/2020	July 24, 2020 Approval Letter - TECARTUS
7/24/2020	CBER-Regulated Products: Current Shortages
7/22/2020	2020 Biological Device Application Approvals
7/22/2020	2020 Biological License Application Approvals
7/22/2020	2020 Biological License Application Supplement Noteworthy Approvals
7/22/2020	Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes
7/22/2020	Reporting Adverse Events Related to Stem Cells, Exosomes, or Other Products Marketed as Regenerative Medicine Products
7/20/2020	TRG Rapid Inquiry Program (TRIP)
7/20/2020	Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff