Nabin, Munirul Haque; Mohan, Vijay; Nicholas, Aaron; … - In: The B.E. Journal of Economic Analysis & Policy 12 (2012) 1
Abstract Following the passage of the Waxman-Hatch Act (1984), FDA approval for a generic drug requires the establishment of bio-equivalence between the generic drug and an FDA approved branded drug. However, a large body of evidence in the medical community suggests that bio-equivalence does...
