Priority Review

An FDA designation that shortens the review period for a new drug application from the standard 10 months to 6 months. Granted to drugs that offer significant improvements in the treatment, diagnosis, or prevention of a serious condition. Does not alter the scientific standard for approval but accelerates the evaluation timeline.

ตัวอย่าง

• Keytruda (pembrolizumab) for melanoma
• Eliquis (apixaban) for stroke prevention
• Entresto (sacubitril/valsartan) for heart failure