What’s New for Biologics | FDA

What’s New for Biologics | FDA

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Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry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