FDA Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations

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Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations[附网盘链接]是于不久前发布的FDA标准，适用于U.S。

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Determining the Extent of Safety Data Collection Needed in Late-

Stage Premarket and Postapproval Clinical Investigations

1 Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance is intended to help sponsors determine the amount and types of safety data to collect during late-stage premarket and postapproval clinical investigations, (e.g., phase 3 clinical trials, studies of new uses, long-term outcomes). This guidance discusses a selective approach to safety data collection during late-stage premarket development or during the 2

postapproval stage based on what is already known about a drug’s safety profile. This guidance provides recommendations on when to consider selective safety data collection and how to do so to maintain a balance between eliminating the collection of data that will not be useful and collecting sufficient data to allow adequate characterization of the safety profile of a drug. In addition, this guidance provides information to sponsors about consulting with the relevant FDA review division or divisions to determine whether a selective approach to safety data collection would be appropriate (see section V of this guidance). This guidance is intended to apply to safety data collection during late-stage premarket and postapproval clinical investigations in all disease settings except rare diseases (see section III of this guidance). There is an existing FDA guidance that applies to the collection of clinical data 3

in all phases of oncology clinical trials, but that guidance does not discuss selective safety data 1 This guidance has been prepared by the Office of Medical Policy in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research at the Food and Drug Administration. 2

For the purposes of this guidance, all references to drugs or drug products include both human drugs and biological drug products regulated by the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research unless otherwise specified. 3

See the guidance for industry Cancer Drug and Biological Products – Clinical Data in Marketing Applications. We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 1

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