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FDA requires increased disclosure of bioequivalence studies for ANDA applicants
  • Gowling WLG
  • USA
  • February 9 2009

Effective July 15, 2009, the U.S. Food and Drug Administration (FDA) will require applicants of an abbreviated new drug application (ANDA) to submit all data from bioequivalence studies that have been conducted on the particular drug formulation submitted for approval.

Isabel Raasch
  • Gowling WLG

Scott E. Foster
  • Gowling WLG

James D. Baker
  • Gowling WLG

Denis Kolesnikov
  • Gowling WLG

Gordon Harris
  • Gowling WLG