U.S. Enacts Bill Creating Generic Drug User Fee Program

President Obama has signed into law a measure that will revise FDA’s ability to oversee certain provisions related to pharmaceutical ingredients and includes a generic drug user fee program. The new statute represents a significant victory for Socma, which for years has been urging lawmakers to take steps to make sure U.S. makers of active pharmaceutical ingredients (APIs) do not face unfair competition from overseas producers. It also is one of the few industry-related measures to pass Congress this year.  "For too long, the U.S. drug supply...

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