What’s New for Biologics | FDA

What’s New for Biologics | FDA

Posted: 4/16/2020 Summary of Safety and Effectiveness-Elecsys HIV Duo 2020 Biological License Application Approvals 2020 Biological License Application Supplement Noteworthy Approvals 2020 Biological Device Application Approvals

4/16/2020	Summary of Safety and Effectiveness-Elecsys HIV Duo
4/16/2020	2020 Biological License Application Approvals
4/16/2020	2020 Biological License Application Supplement Noteworthy Approvals
4/16/2020	2020 Biological Device Application Approvals
4/15/2020	April 14, 2020 Approval Letter - FluMist
4/10/2020	April 10, 2020 Approval Letter - Elecsys HIV Duo
4/9/2020	Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation - Screening Donors for COVID-19 and Exposure to SARS-CoV-2 and Testing for SARS-CoV-2
4/9/2020	User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act
4/8/2020	Recommendations for Investigational COVID-19 Convalescent Plasma
4/8/2020	Investigational COVID-19 Convalescent Plasma; Guidance for Industry
4/6/2020	Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation -- Testing of Stool Donors for Enteropathogenic Escherichia coli and Shigatoxin-Producing Escherichia coli
4/6/2020	eSubmitter Application History
4/3/2020	Investigational COVID-19 Convalescent Plasma - Emergency INDs
4/3/2020	March 30, 2020 Summary Basis for Regulatory Action - DG Gel 8 ABO/Rh (2D)
4/3/2020	Regenerative Medicine Advanced Therapy Designation
4/3/2020	April 1, 2020 Untitled Letter - Dynamic Stem Cell Therapy
4/2/2020	Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency; Guidance for Industry
4/2/2020	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
4/2/2020	Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry
4/2/2020	Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry
4/2/2020	Expiration Date Extension for Anavip [Crotalidae Immune F(ab’)2 (Equine)]: Lot B-8G-33 through July 31, 2021; Lot B-9B-33 through February 28, 2022; and Lot B-9E-35 through June 30, 2022
4/2/2020	Complete List of Licensed Products and Establishments
4/2/2020	Complete List of Substantially Equivalent 510(k) Device Applications
4/2/2020	Complete List of Currently Approved Premarket Approvals (PMAs)
4/2/2020	Complete List of Currently Approved NDA and ANDA Application Submissions
4/1/2020	Updated Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the Coronavirus Disease 2019 Pandemic
4/1/2020	CBER Vacancy: Staff Fellow – Bioinformatics (Individualized Cell and Gene Therapies)
4/1/2020	April 1, 2020 Approval Letter -SEVENFACT
4/1/2020	April 1, 2020 Approval Letter - Fluzone Quadrivalent
4/1/2020	March 30 Approval Letter - DG Gel 8 ABO/Rh (2D)
3/27/2020	Letter to Sponsors, Applicants and Regulated Entities on COVID-19
3/27/2020	Summary of FDA & EMA Global Regulators Meeting on Data Requirements Supporting First-in-Human Clinical Trials with SARS-CoV-2 Vaccines
3/26/2020	Investigational COVID-19 Convalescent Plasma - Emergency INDs Frequently Asked Questions
3/26/2020	2020 Biological License Application Supplement Noteworthy Approvals
3/26/2020	2020 Biological Device Application Approvals
3/26/2020	TRG Rapid Inquiry Program (TRIP)
3/24/2020	March 23, 2020 Approval Letter - VAXELIS
3/24/2020	Investigational COVID-19 Convalescent Plasma - Emergency INDs
3/23/2020	March 20, 2020 Approval Letter - Typhim Vi
3/23/2020	Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19
3/20/2020	March 20, 2020 Approval Letter - Fluarix Quadrivalent
3/19/2020	Updated Instructions for Submitting Lot Release Samples and Protocols for CBER-regulated Products During the COVID-19 Pandemic
3/18/2020	Complete List of Donor Screening Assay for Infectious Agents and HIV Diagnostic Assays
3/18/2020	March 13, 2020 Approval Letter - ALBAclone BL 125304-69 et al.