FDA’s MRCT Guidance Is Here. Are You Ready? Geography once stood in for diversity — but genetics, standards of care, and epidemiology don’t follow borders. FDA’s new MRCT guidance makes it clear: global data fails if it doesn’t apply to U.S. patients. This new whitepaper by Precision’s CMO and former FDA Oncology Division Director, Dr. Harpreet Singh, explains what regulators expect and how to position your program for approval.