Regulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 6: Safety Reporting in Industry-Sponsored Trials and Case Studies - Part 2 (2018)

1. Exercise-2: Clinical Trial Adverse Event for a drug approved for a different indication
   The case study talks about a prescription drug that has been approved for a different indication for which a rare serious adverse reaction (SAR) is reported. In this case, what changes can be expected by the FDA?
2. Exercise-3: Medical Device Trial Report
   The case study discusses how fast Medical Device Reporting (MDR) has to be done for an investigational device in case of serious injury to the subject/s.

Accompanying text created by Khyati Ashtekar | Graduate Student, Regulatory Science, USC School of Pharmacy | ashtekar@usc.edu