A recent draft guidance announced by Food and Drug Administration Commissioner Scott Gottlieb looks to give generic drugs a clearer regulatory path by curbing brand drugmakers’ strategies that delay generic competition.
According to a Seeking Alpha brief, generic drugmakers under the proposed policy will have the opportunity to apply for a waiver of the Single Shared System REMS Requirement, which would allow them to instead use a comparable risk evaluation and mitigation strategy.
“We believe that by making the process for developing a shared system REMS more efficient, we’ll discourage brand drug makers from using REMS as a way to block generic entry and help end some of the tactics that can delay access,” Gottlieb says in his statement.
No kind of comment period is mentioned in Gottlieb’s statement.
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