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April 20, 2020

E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting

Docket Number: FDA-2003-D-0371 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research It is important to establish an […]
April 20, 2020

E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, Center for Biologics […]
April 20, 2020

E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers

Docket Number: FDA-2016-17009 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 20, 2020

E2BM Data Elements for Transmission Of Individual Case Safety Reports

Docket Number: FDA-1996-D-0168 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 20, 2020

Recommendations for the Submission of LOINC® Codes in Regulatory Applications to the U.S. Food and Drug Administration

Docket Number: FDA-2017-D-6982 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Regulated clinical research is carried out […]
April 20, 2020

Most Common Issues with CDISC-SEND Data in FDA Toxicology Review – Sep. 12, 2019

Follow us on LinkedIn [embedded content] View Slides This on-demand webinar is FREE. This webinar was recorded on September 12, 2019. FDA discusses trends with the Clinical […]
April 20, 2020

Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments

Docket Number: None found Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This document provides current specifications […]
April 20, 2020

Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use

Docket Number: FDA-1994-D-0318 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research Office of Medical Products and Tobacco, […]
April 20, 2020

E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility

Docket Number: FDA-1996-D-0168 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Implementation of ICH E2B(R3) The E2B(R3) […]
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