Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities
Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products
Application of Human Factors Engineering Principles for Combination Products: Questions and Answers
Application of Human Factors Engineering Principles for Combination Products: Questions and Answers
Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products
Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products is about guidance provides recommendations to institutional review boards (IRBs) and clinical investigators regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions, including for reviews conducted by a single member of […]
Benefit-Risk Assessment for New Drug and Biological Products
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 a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the Food and Drug Administration (FDA or Agency) makes about new drug applications (NDAs) […]
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 to support a marketing application for a medical product in oncology, where a PRO is a type of clinical outcome assessment (COA) used to collect patient experience data.
Real-Time Oncology Review (RTOR)
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 early as possible, while improving review quality and engaging in early iterative communication with the applicant.
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 Act (21 U.S.C. 379k-1(a)) when submitting RWD as study data in applicable drug submissions.
Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization
FDA is issuing (Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization) guidance to provide recommendations to sponsors on the development of monoclonal antibody (mAb) products targeting SARS-CoV-2 intended for the prevention or treatment of COVID-19, including recommendations on addressing the impact of emerging variants.