The U.S. Food and Drug Administration (FDA) has developed a new learning tool to help the public better understand the drug regulation process.
The instructional case studies are to be used by patients and patient advocacy groups, health professionals, small businesses and pharmaceutical and clinical innovators.
The tool provides information about the processes of drug regulation. Using case studies, it promotes active learning with exercises, instructor-led discussions and quizzes.
The first case study, "Drug Approval: Bringing a New Drug to the Market," takes learners through the navigation of the drug approval process, covering topics from non-clinical testing and clinical trials to submitting a new drug application to FDA.
"We plan to develop new drug case studies that address other regulatory activities," said a statement posted on the FDA website this week.
Ideas for case study topics are welcome and can be sent to the Professional Affairs and Stakeholders Engagement (PASE) group at cderpase@fda.hhs.gov.
