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FDA Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations

蒋千琴 10/23/2021 浏览 273 FDA U.S

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Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations[附网盘链接]是于之前发布的FDA标准，适用于U.S。

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Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations[附网盘链接]
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations[附网盘链接](截图)

 

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Draft — Not for Implementation 1 Assessing the Effects of Food on Drugs in INDs and NDAs — 2 Clinical Pharmacology Considerations 1

3 Guidance for Industry 4 5 6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 10 for this guidance as listed on the title page. 11 12 13 14 15 I. INTRODUCTION 16 17 This guidance provides recommendations to sponsors planning to conduct food-effect (FE) 18 studies for orally administered drug products as part of investigational new drug applications 19 (INDs), new drug applications (NDAs), and supplements to these applications. This guidance 20 revises and replaces part of the 2002 FDA guidance for industry entitled Food-Effect 21 Bioavailability and Fed Bioequivalence Studies. Information on fed bioequivalence (BE) 22 studies to be submitted in abbreviated new drug applications (ANDAs) is now found in the 23 FDA draft guidance for industry entitled Bioequivalence Studies with Pharmacokinetic 2

24 Endpoints for Drugs Submitted Under an ANDA. Specific recommendations concerning fed 25 comparability trials are now described in the FDA draft guidance for industry entitled 3 26 Bioavailability Studies Submitted in NDAs or INDs — General Considerations. 27 28 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 29 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 30 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 31 the word should in Agency guidances means that something is suggested or recommended, but 32 not required. 33 34 35 II. BACKGROUND 36 1

This guidance has been prepared by the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2

We update guidances periodically. To make sure you have the most recent version of guidance, check the FDA Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. When final, this guidance will represent the FDA’s current thinking on this topic 3

When final, this guidance will represent the FDA’s current thinking on this topic. 02/21/19

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