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Regulatory Focus™ > News Articles > It’s the Law: Enantiomer Exclusivity Revisited: The Food and Drug Administration Amendments Act of

It’s the Law: Enantiomer Exclusivity Revisited: The Food and Drug Administration Amendments Act of 2007

Posted 01 February 2008

Tucked away at the end of the Food and Drug Administration Amendments Act of 2007 (FDAAA) is a provision that modifies FDA's longstanding refusal to award five-year new chemical entity (NCE) exclusivity to enantiomers of previously approved racemic mixtures.1

 

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