viernes, 31 de enero de 2020

What’s New for Biologics | FDA

What’s New for Biologics | FDA







1/30/2020Clinical Review - Agriflu
1/30/2020Statistical Review - Agriflu
1/30/2020Recommendations 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Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry
1/29/2020January 28, 2020 Approval Letter - Agriflu
1/28/2020Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry
1/28/2020Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Guidance for Industry
1/28/2020Human Gene Therapy for Retinal Disorders; Guidance for Industry
1/28/2020Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry
1/28/2020Human Gene Therapy for Rare Diseases; Guidance for Industry
1/28/2020Human Gene Therapy for Hemophilia; Guidance for Industry
1/28/2020Long Term Follow-Up After Administration of Human Gene Therapy Products; Guidance for Industry
1/24/2020January 22, 2020 Approval Letter - PROCLEIX WNV ASSAY
1/24/2020January 23, 2020 Approval Letter - Afluria and Afluria Quadrivalent
1/23/2020January 22, 2020 Approval Letter - DENGVAXIA
1/22/2020BK190439 - MATCH IT! DNA (version 1.3)
1/22/20202019 Biological Device Application Approvals
1/22/20202019 Biological License Application Supplement Noteworthy Approvals
1/22/20202019 Biological License Application Approvals
1/17/2020Vaccines and Related Biological Products Advisory Committee March 4, 2020 Meeting Announcement
1/15/2020December 19, 2019 Summary Basis for Regulatory Action - ERVEBO
1/13/2020CBER Vacancy: Physician, Division of Epidemiology (DE)
1/10/2020Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies – Transcript
1/10/2020January 8, 2020 Approval Letter - GRASTEK
1/9/2020CBER-Regulated Products: Current Shortages
1/7/2020CBER Vacancy: Senior Staff Fellow – Allergic Diseases
1/6/2020Complete List of Licensed Products and Establishments
1/6/2020Complete List of Substantially Equivalent 510(k) Device Applications
1/6/2020Complete List of Currently Approved Premarket Approvals (PMAs)
1/6/2020Complete List of Currently Approved NDA and ANDA Application Submissions
1/2/2020Microparticles from sickle cell disease rbcs
12/26/2019FY 2019 Report from the Director
12/23/2019December 23, 2019 Approval Letter - Afluria and Afluria Quadrivalent
12/23/2019BK190424 - IH-COM V5.2
12/23/2019Importation 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

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