Draft Guidance for Industry, Preparation of the Quality Information for Radiopharmaceuticals (Schedule C Drugs) using the Quality Information Summary-Radiopharmaceuticals (QIS-R) and Certified Product Information Document (English, HTML)

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HTML

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Publisher-reported update

2022-06-07

The purpose of this guideline is to provide sponsors of New Drug Submissions (NDSs) and related submissions (responses to information requests during the review, Responses to Notices of Deficiency or Non-Compliance (NODs/NONs), Supplemental New Drug Submissions (SNDSs), and Notifiable Changes (NCs)including Clinical Trial Applications (CTA) with approaches that acceptably meet the regulatory requirements that apply to the "Quality" (chemistry and manufacturing) portions of submissions.

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