What’s New for Biologics | FDA

What’s New for Biologics | FDA

7/31/2020	CBER-Regulated Products: Resolved Shortages
7/31/2020	CBER-Regulated Products: Current Shortages
7/29/2020	Influenza Vaccine for the 2020-2021 Season
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
7/16/2020	Considerations for the Use of Real-World Evidence to Assess the Effectiveness of Preventive Vaccines
7/14/2020	Diagnosis and Pathogenesis of Hepatitis Viruses That Impact the Safety of Blood and Related Products
7/13/2020	Understanding the Interplay Between Host Immunity and Viral Factors for Rational Design of Vaccines Against Vector-Borne Viral Pathogens
7/10/2020	Study of antibody response to SARS-CoV-2 spike proteins could help inform vaccine design
7/10/2020	July 9, 2020 Approval Letter - FluMist
7/9/2020	Regenerative Medicine Advanced Therapy Designation
7/7/2020	Summary of Safety and Effectiveness  - Alinity m HIV-1
7/6/2020	July 2, 2020 Approval Order - Alinity m HIV-1
7/6/2020	July 2, 2020 Approval Letter - Flucelvax
7/6/2020	July 2, 2020 Approval Letter - Fluad and Fluad Quadrivalent
7/6/2020	July 2, 2020 Approval Letter - FluLaval
7/2/2020	July 2, 2020 Approval Letter - Afluria
7/2/2020	July 2, 2020 Approval Letter - Fluarix Quadrivalent
7/2/2020	July 2, 2020 Approval Letter - Flublok
7/2/2020	July 2, 2020 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent
7/2/2020	Influenza Vaccine for the 2020-2021 Season
7/2/2020	Updated Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the COVID-19 Pandemic
7/2/2020	Complete List of Licensed Products and Establishments
7/2/2020	Complete List of Substantially Equivalent 510(k) Device Applications
7/2/2020	Complete List of Currently Approved Premarket Approvals (PMAs)
7/2/2020	Complete List of Currently Approved NDA and ANDA Application Submissions
7/2/2020	Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases
7/1/2020	Expiration Date Extension for MicRhoGAM (Rho(D) Immune Globulin) Lot MVP116A1 through July 19, 2021