FDA, EMA To Share Generic Drug Inspection Duties

Law360, New York (December 18, 2013, 2:06 PM EST) -- The U.S. Food and Drug Administration and the European Medicines Agency said Wednesday they are teaming up to vet studies submitted in support of generic drug approvals.

A joint initiative between the two agencies will allow them to share information on inspections of bioequivalence studies companies submit to gain approval of new generic drugs. The initiative creates a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies.

Studies submitted for generic drug applications must demonstrate scientifically that a generic drug is...
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