federal_register: 2012-3233

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2012-3233 Draft Guidance for Industry on Bioequivalence Recommendation for Nitroglycerin Metered Spray/Sublingual Products and Metered Aerosol/Sublingual Products; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of two draft guidances for industry entitled ``Bioequivalence Recommendations for Nitroglycerin,'' one for nitroglycerin metered spray/sublingual products and one for nitroglycerin metered aerosol/sublingual products. The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for these products. The draft guidances are revised versions of previously published draft guidances on the subject. 2012-02-13 2012 2 https://www.federalregister.gov/documents/2012/02/13/2012-3233/draft-guidance-for-industry-on-bioequivalence-recommendation-for-nitroglycerin-metered https://www.govinfo.gov/content/pkg/FR-2012-02-13/pdf/2012-3233.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of two draft guidances for industry entitled ``Bioequivalence Recommendations for Nitroglycerin,'' one for nitroglycerin metered spray/sublingual products and one for nitroglycerin...

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