WASHINGTON, Aug. 23 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register. * * * The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry titled "Evaluation of Therapeutic Equivalence." This guidance explains FDA's thinking on therapeutic equivalence evaluations and therapeutic equivalence codes. FDA's therapeutic equivalence evaluations are listed for multisource prescription drug products approved under the Fe more PR

WASHINGTON, Aug. 23 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register. * * * The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the ava more PR

WASHINGTON, Aug. 23 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register. * * * The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews. This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 066", will assist manufacturers who elect to declare conformity with consensus standards to m more PR