Federal Register: FDA Releases Updated Draft Guidelines Supporting Generic Drug Approvals
August 23, 2026
August 23, 2026
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.
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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 application . . .
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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 application . . .