Thyrotropin stimulates radioiodine uptake for scanning in patients with thyroid cancer, but the sensitivity of scanning after the administration of thyrotropin is less than that after the withdrawal of thyroid hormone. Thyrotropin scanning is associated with fewer symptoms and dysphoric mood states.

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RIOR REPORTS SUGGESTED THAT rapidly progressive, bilateral, asymmetric inner ear dysfunction may be caused by immunological attack or may be associated with autoimmune disorders. 1-3 McCabe 4 renewed interest in this disorder as a distinct clinical entity and motivated investigators to identify the most efficacious treatment regimens for management of this potentially reversible form of deafness. Initial experience with this disorder has underscored the risk of developing bilateral profound deafness and vestibulopathy if patients are left untreated or treated inadequately.On empirical grounds, glucocorticoids and cytotoxic agents were initially proposed as treatments. In a fol-

Background The purpose of this study was to describe the experience of the Center of Drug Evaluation and Research (CDER) with expanded access of investigational drugs. Methods Multiple searches of CDER’s document tracking system were performed to identify the number, type, and indication for all expanded access requests over the 10-year time period of January 2005 through December 2014. An additional search was performed to identify all active commercial investigational drug development programs during that time period and whether or not the clinical program was placed on hold. The two searches were then cross-referenced to identify those commercial investigational drug development programs placed on clinical hold due to serious adverse events occurring within expanded access programs. Results CDER receives over 1000 applications for expanded access each year. The majority are for single patients, roughly evenly split between emergency and nonemergency use. The vast majority, 99.7%, are allowed to proceed. The incidence of clinical holds for all commercial investigational drug development programs is 7.9%, as compared to only 0.2% related to adverse events observed in patients receiving drug treatments under expanded access. Conclusions The expanded access program is viewed as a success from FDA’s perspective based on the large number of applications processed and allowed to proceed each year. However, the actual number of patients and their health care providers that desire drug treatments available under expanded access is not known. It is exceedingly rare for a serious adverse event under expanded access to affect the development program for that drug.