Trump's Budget Request To Include ANDA Exclusivity Changes
180-day exclusivity would begin when a second ANDA is approvable, rather than at first-generic's launch, a potentially major change to the Hatch-Waxman framework if implemented.
You may also be interested in...
President Trump has directed his new HHS Secretary to bring down drug prices – starting 2018 exactly the same way as 2017. But this time it could end differently.
HHS secretary will get US drug prices 'way down … because it’s very unfair to our country,' president says. Also, 'we’re going to be very tough' on drug companies in combating the opioid crisis, Trump says.
Amid confusion about multiple priority and expedited pathways for US generic drug applications, industry asks which are a true advantage.