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Documents recently posted on the CBER Web Site



Last Build Date: Mon, 01 Jun 2009 10:59:00 -0400

 



Regulatory Submissions in Electronic Format for Biologic Products

Mon, 18 Dec 2017 06:05:00 -0500

FDA has started the transition to a more automated electronic review process for these submissions.



Evolving Data Mining System is Designed to Speed Identification of Adverse Events Following Vaccinations

Wed, 13 Dec 2017 11:46:00 -0500

This page is about Evolving Data Mining System is Designed to Speed Identification of Adverse Events Following Vaccinations



Guidance for Industry: Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application

Wed, 29 Nov 2017 16:42:00 -0500

This is the Guidance for Industry: Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application.



Drug Master Files for CBER-Regulated Products

Tue, 21 Nov 2017 16:10:00 -0500

Drug Master Files for CBER-Regulated Products



SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA)- pdf

Mon, 20 Nov 2017 10:01:00 -0500

This is the CBER SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA).