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April 20, 2020

E2E Pharmacovigilance Planning

Docket Number: FDA-2004-D-0245 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

FDA grants accelerated approval to pemigatinib for cholangiocarcinoma with an FGFR2 rearrangement or fusion

On April 17, 2020, the Food and Drug Administration granted accelerated approval to pemigatinib (PEMAZYRE, Incyte Corporation) for the treatment of adults with previously treated, unresectable […]
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 […]
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