Application of Human Factors Engineering Principles for Combination Products: Questions and Answers
Application of Human Factors Engineering Principles for Combination Products: Questions and Answers
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Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products is about guidance provides recommendations to institutional…
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Benefit-Risk Assessment for New Drug and Biological Products intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about…
Read more →Submitting Patient-Reported Outcome Data in Cancer Clinical Trials
Submitting Patient-Reported Outcome Data in Cancer Clinical Trials. This document provides technical specifications for submitting patient-reported outcome (PRO) data collected in cancer clinical trials…
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Real-Time Oncology Review (RTOR) aims to provide a more efficient review process to ensure that safe and effective treatments are available to patients as…
Read more →Data Standards for Drug and Biological Product Submissions Containing Real-World Data
Data Standards for Drug and Biological Product Submissions Containing Real-World Data guidance provides recommendations to sponsors for complying with section 745A(a) of the FD&C…
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