Code of Federal Regulations Title 21. Food and Drugs § 21.516.30 Annual reports for a MUMS–designated drug

(a) A short account of the progress of drug development including a description of studies initiated, ongoing, and completed, and a short summary of the status or results of such studies;

(b) A description of the investigational plan for the coming year, as well as any anticipated difficulties in development, testing, and marketing;  and

(c) A brief discussion of any changes that may affect the MUMS–designated drug status of the product. For example, situations in which testing data demonstrate that the proposed intended use is inappropriate due to unexpected issues of safety or effectiveness.