FDA CVM GFI #197 Documenting Electronic Data Files and Statistical Analysis Programs

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Documenting Electronic Data Files and Statistical Analysis Programs 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 staff responsible for this guidance as listed on the title page. I. Introduction This guidance is provided to inform sponsors of recommendations for documenting electronic data files and statistical analyses submitted to the Center for Veterinary Medicine (CVM) to support new animal drug applications. These recommendations are intended to reduce the number of revisions that may be required for CVM to effectively review data submissions. They are also intended to simplify submission preparation for sponsors by providing a suggested documentation framework, including a sample structure on how to describe and organize the information regarding the electronic data files and statistical analysis programs. The determination of what data and analysis are needed to support a new animal drug application may vary depending on many factors and is outside the scope of this document. You should refer only to those portions of this guidance that are applicable to your particular submission. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. II. Background For new animal drug applications, FDA requires full reports of investigations which have been conducted to show a drug is safe and effective for use [section 512(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)]. Additionally, section 512(n)(1)(E) of the FD&C Act requires that abbreviated applications for the approval of a new animal drug contain information to show that the new animal drug is bioequivalent to the approved new animal drug. Submissions to CVM in support of new animal drug applications generally include a Final Study 1

Report (FSR) for one or more studies. For each study that includes electronic data files, CVM 1

For the purpose of this guidance, supporting study reports (e.g., statistical or bioanalytical phase reports) appended to the FSR are considered part of the FSR.

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