Examples of Accelerated Approval in a sentence
Accelerated Approval can be applied to promising therapies that treat a serious or life-threatening condition and provide therapeutic benefit over available therapies.
If further trials fail to verify the predicted clinical benefit, FDA may withdraw approval.Since the Accelerated Approval pathway was established in 1992, many drugs that treat life-threatening diseases have successfully been brought to market this way and have made a significant impact on disease course.
No assurance can be given in these regards.Given the high unmet medical need in AML, we believe successful determination of objective clinical response at tolerated doses may form the basis for Breakthrough Status and FDA Accelerated Approval.
Meridian Parkway, #340Tel: (919) 806-1074Durham, NC 27713Fax: (919) 806-1146Data from SUPPRESS are anticipated in mid-2015 and, if positive, may support Accelerated Approval of brincidofovir for the prevention of CMV infection.
These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as FDA guidance on an efficient drug development program.