Generics REMS Hurdles Lowered Somewhat By FDA Protocol Letters
This article was originally published in The Pink Sheet Daily
Executive Summary
But FDA still cannot force brand firms to provide product for bioequivalence testing, which may limit policy’s ability to remove barrier that generic firms allege some NDA sponsors use to block competition.
You may also be interested in...
FDA Exploring Whether Public Shaming Can Stop REMS Abuses
Commissioner Gottlieb says agency is considering publicizing letters it has written to brand companies indicating it would not violate a REMS to sell a generic company samples for testing.
FDA Exploring Whether Public Shaming Can Stop REMS Abuses
Commissioner Gottlieb says agency is considering publicizing letters it has written to brand companies indicating it would not violate a REMS to sell a generic company samples for testing.
US Comparator Requirement For Interchangeable Biosimilars Would Hurt Industry
US FDA’s recommendation against use of foreign-licensed reference products in clinical switching studies would result in procurement challenges and higher costs for biosimilar developers while also limiting where such studies could be conducted, some companies say.