GDUFA guarantees a decision within 10 weeks, which is considerably better than the running average before and even extreme cases such as 13 years before address

GDUFA guarantees a decision within 10 weeks, which is considerably better than the running average before and even extreme cases such as 13 years before addressing applications. There are unfortunately many cases that have been decided on the basis of finances rather than clinical justifications. I don’t envy the agency, stuck between the disdain of the public, pressure from industry, and continually having to justify their existence to Congressional committees.