FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents, seek public comment

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will take to ensure that the Orange Book (FDA's publication of Approved Drug Products with Therapeutic Equivalence Evaluations) provides the greatest benefit to patients, providers, and – perhaps in particular – generic-drug developers.

The commissioner's announcement addresses several important issues, including patent listing standards and therapeutic equivalence ratings.

Read More: FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents, seek public comment


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