Attorneys Mixed On Whether FDA Should Make 180- Day Exclusivity Process Public

FDA may get mixed views from industry attorneys at a public meeting Wednesday set up to gather feedback on the idea of using a public process to consider a generic drug's eligibility for 180-day exclusivity. Such a process could provide industry with a clear path forward and resolve issues early-on related to exclusivity challenges, but it also could delay the process by drawing in more lawsuits and citizen petitions, said industry attorneys. The agency announced back in August that it...