Abstract
After a drug receives marketing authorization in the United States, the FDA and the applicant work together to monitor patient safety and mitigate any risks associated with the use of the drug. The process requires collecting and reporting data from a variety of sources, analyzing the data, devising strategies to minimize risk, and disseminating information. This chapter reviews the basic information contained within required FDA submissions, provides an overview of risk management plans, reviews the role of the Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research, and highlights resources that are available for applicants to support compliance with postmarketing safety regulations.
Original language | English (US) |
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Title of host publication | Translational Radiation Oncology |
Publisher | Elsevier |
Pages | 507-511 |
Number of pages | 5 |
ISBN (Electronic) | 9780323884235 |
ISBN (Print) | 9780323884242 |
DOIs | |
State | Published - Jan 1 2023 |
Keywords
- Adverse drug experiences
- Adverse events
- FDA
- Postmarket safety
- Reporting requirements
- Risk evaluation
- Risk mitigation
ASJC Scopus subject areas
- General Agricultural and Biological Sciences
- General Biochemistry, Genetics and Molecular Biology