What’s New for Biologics | FDA

What’s New for Biologics | FDA

January 28, 2020 Approval Letter - Agriflu

Posted: 1/29/2020

1/30/2020	Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry
1/29/2020	January 28, 2020 Approval Letter - Agriflu
1/28/2020	Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry
1/28/2020	Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Guidance for Industry
1/28/2020	Human Gene Therapy for Retinal Disorders; Guidance for Industry
1/28/2020	Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry
1/28/2020	Human Gene Therapy for Rare Diseases; Guidance for Industry
1/28/2020	Human Gene Therapy for Hemophilia; Guidance for Industry
1/28/2020	Long Term Follow-Up After Administration of Human Gene Therapy Products; Guidance for Industry
1/24/2020	January 22, 2020 Approval Letter - PROCLEIX WNV ASSAY
1/24/2020	January 23, 2020 Approval Letter - Afluria and Afluria Quadrivalent
1/23/2020	January 22, 2020 Approval Letter - DENGVAXIA
1/22/2020	BK190439 - MATCH IT! DNA (version 1.3)
1/22/2020	2019 Biological Device Application Approvals
1/22/2020	2019 Biological License Application Supplement Noteworthy Approvals
1/22/2020	2019 Biological License Application Approvals
1/17/2020	Vaccines and Related Biological Products Advisory Committee March 4, 2020 Meeting Announcement
1/15/2020	December 19, 2019 Summary Basis for Regulatory Action - ERVEBO
1/13/2020	CBER Vacancy: Physician, Division of Epidemiology (DE)
1/10/2020	Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies – Transcript
1/10/2020	January 8, 2020 Approval Letter - GRASTEK
1/9/2020	CBER-Regulated Products: Current Shortages
1/7/2020	CBER Vacancy: Senior Staff Fellow – Allergic Diseases
1/6/2020	Complete List of Licensed Products and Establishments
1/6/2020	Complete List of Substantially Equivalent 510(k) Device Applications
1/6/2020	Complete List of Currently Approved Premarket Approvals (PMAs)
1/6/2020	Complete List of Currently Approved NDA and ANDA Application Submissions
1/2/2020	Microparticles from sickle cell disease rbcs
12/26/2019	FY 2019 Report from the Director
12/23/2019	December 23, 2019 Approval Letter - Afluria and Afluria Quadrivalent
12/23/2019	BK190424 - IH-COM V5.2
12/23/2019	Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry