Elite Pharmaceuticals Inc (ELTP)

[sharkey1]

It cost a lot of money to file an NDA.

The industry, however, “is incentivized to try to get the maximum it can for its user-fee contributions,” he says, and increased safety surveillance that could lead to more product recalls “doesn’t financially benefit them.” At a meeting last summer, an FDA official put it bluntly: “User fees pay for services that directly benefit fee payers,” he said. “This is what distinguishes it from a tax.”

Major pharmaceutical companies generally don’t disclose their user-fee payments. Standard rates for 2021 include roughly $2.9 million for a new prescription-drug application with clinical data and a $336,000 “program fee” levied annually on certain products.

I don't know how much for anda, but I know it's not cheep

they gotta fix this problem