What’s New for Biologics | FDA

What’s New for Biologics | FDA

5/21/2019	Framework for the Regulation of Regenerative Medicine Products Updated as of 5/21/2019
5/17/2019	SHINGRIX
5/17/2019	2019 Biological License Application Approvals Updated as of 4/30/2019
5/17/2019	2019 Biological License Application Supplement Noteworthy Approvals Updated as of 4/30/2019
5/17/2019	2019 Biological Device Application Approvals Updated as of 4/30/2019
5/17/2019	Regenerative Medicine Advanced Therapy Designation Updated as of 5/17/2019
5/16/2019	May 1, 2019 Summary Basis for Regulatory Action - DENGVAXIA
5/15/2019	BK190322 - NBM-200 Pulse Oximeter and Hemoglobin Monitor
5/9/2019	Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Guidance for Industry
5/8/2019	Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2017