E22 General Considerations for Patient Preference Studies; International Council for Harmonisation; Draft Guidance for Industry; Availability
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "E22 General Considerations for Patient Preference Studies." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). When finalized, this guidance will provide general principles for the use, design, conduct, analysis, and submission of patient preference studies (PPS) aimed at informing drug development, regulatory submission and evaluation, drug approvals, and maintenance of such approvals.
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