FDA Shames Anti-Generic Tactics, Putting Onus On Congress
The shaming marked the latest salvo in FDA Commissioner Scott Gottlieb's campaign against "shenanigans" by brand-name drugmakers. At issue are "risk evaluation and mitigation strategies," or REMS, that restrict distribution of riskier prescription drugs and can be cited to withhold samples that generics makers need to develop copycat products.
In a list posted online, the FDA...
To view the full article, register now.