A “skinny label” is one way that a generic drug can be commercialized in the US when only a subset of the brand’s uses lose exclusivity. The recent Supreme Court decision in the Caraco case may put a spotlight on the opportunities for “skinny label” generics. The article found here describes some of the issues and possible policy implications that may be associated with an increased use of “skinny labels.”
Roundtable: Transitioning Medical Affairs to strategically co-lead clinical development and commercialization efforts
In May 2023, CRA’s Life Sciences Practice held a roundtable discussion with Medical Affairs leaders in Lisbon on best practices in transitioning from a...