domingo, 19 de enero de 2020

What’s New for Biologics | FDA

What’s New for Biologics | FDA





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Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry
12/20/2019December 20, 2019 Approval Letter - MENVEO
12/20/2019December 19, 2019 Approval Letter - ERVEBO
12/20/2019Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review; Guidance for Industry; Technical Specifications Document
12/20/2019Important Information for Potential Donors of Blood and Blood Products
12/20/2019TRG Rapid Inquiry Program (TRIP)
12/20/2019BK190401 - ZipThaw™ 202
12/19/2019BK190400 - MTS™ Buffered Gel Card
12/19/2019BK190399 - ORTHO VISION Max Analyzer
12/19/2019Considerations for the Development of Dried Plasma Products Intended for Transfusion; Guidance for Industry
12/18/2019December 17, 2019  Approval Letter - MTS Anti-IgG Card
12/18/2019December 17, 2019 Approval Letter - ORTHO Sera
12/18/20192019 Biological Device Application Approvals
12/18/20192019 Biological License Application Supplement Noteworthy Approvals
12/16/2019BK190388 - TANGO infinity

No hay comentarios: