What’s New for Biologics | FDA

What’s New for Biologics | FDA

Evaluation of Automatic Class III Designation (De Novo) Summaries (CBER)

Posted: 9/30/2019

CBER-Regulated Products: Current Shortages

Posted: 9/30/2019

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Guidance for Industry

Posted: 9/30/2019

9/30/2019	Evaluation of Automatic Class III Designation (De Novo) Summaries (CBER)
9/30/2019	CBER-Regulated Products: Current Shortages
9/30/2019	Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Guidance for Industry
9/27/2019	September 25, 2019 Approval Letter - Wilate
9/27/2019	eSubmitter Application History
9/26/2019	September 26, 2019 Approval Letter - Menveo
9/26/2019	Influenza Vaccine for the 2019-2020 Season
9/24/2019	September 24, 2019 Approval Letter- JYNNEOS
9/23/2019	Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry; Guidance for Industry
9/20/2019	Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products; Draft Guidance for Industry