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October 4, 2019

FDA Announces Availability Of Draft Guidance On Bioequivalency For Soluble Powder Oral Dosage Form P

Lynn L Bergeson

By Lynn L. Bergeson

The U.S. Food and Drug Administration (FDA), on September 30, 2019, announced the availability of a draft guidance for industry (GFI) #171 titled “Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media.” The draft GFI describes how EPA intends to evaluate requests for waiving the requirement for performing in vivo bioequivalence studies for animal drugs administered orally as soluble powders or as Type A medicated articles manufactured from active pharmaceutical ingredients considered to be soluble in aqueous media. EPA is accepting comments on the draft GFI until November 29, 2019, before it starts working on the final version of it.