Preparing Regulatory Submissions with the FDA Reviewer in Mind: Use of the Clinical Review Template and Clinical Safety
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Mary Vanderboof, MS Senior Regulatory Strategist and Medical Writer, Michael Umen S. Co., Glenside. Pennsylvania
Michael J. Urnen, PhD President. Michael Umen & Co., Glenside. Pennsylvania David N. Schwartz, BS Senior Regulatory Strategist and Medical Writer. Michael Umen 6. Co., Glenside. Pennsylvania
Key Words Clinical review template; Clinical safety reviewer guidance: FDA guidance; Common Technical Document; Medical review officer; Clinical overview; Clinical summary Correspoideite Address Dr. Michael 1. h e n , Michael Umen & Co.. 352 North Easton Road, Glenside, PA 19038 (email: mumen @umenandco.com). Information in this article was included in a tutorial titled CTD Preparation: Module 2 Clinical Overview and Clinical Summary presented by two ofthe authors (MV and MjU) at the DIA 41st Annual Meeting. lune 26,2005. Washington. DC.
Both the guidance documents issued by FDA to industry and the guidance documents intended to be used internally by FDAs own staffof medical review officers (MROs) can be effective tods to help sponsors prepare their regulatory submissions. Two recent reviewer guidance documents, the clinical review templateand the correspondingguidance, "Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review," provide useful insight into the FDA review process. The review of the clinical data has always been on the critical path to market approval for new mdecular entities, and the re-
INTRODUCTION Between the years 1938, when President Franklin D. Roosevelt signed into law the Food, Drug and Cosmetic Act, and 1985, when FDA completed an extensive revision of the regulations pertaining to New Drug Applications (NDAs), little existed in the way of guidance from FDA to sponsors on the format and content of NDAs. However, the revisions completed in 1985. commonly referred to as the NDA rewrite (l),ushered in a new era in which FDA began a continuing process of providing sponsors with its most current thinking about the format and content of NDAs in the form of guidance documents. In July 1988. the "Guideline for the Format and Content of the Clinical and Statistical Sections of an Application" was published (2). This guidance, which came to be known as the clin/stat guideline, proved to be an invaluable resource to industry, enabling companies to prepare clinical data for NDA submissions in a format that facilitated, and therefore expedited, agency reviews of the data. Among the key com-
cent reauthorization of the Prescription Drug User Fee Act (PDUFA lv) has underscoredboth the importanceof an efficient review and postmarketing safdy monitoring. The more FDA and the sponsors harmonize their efforts, with sponsors providing the summaries and analyses (including comprehensive tables, figures, and listings) that MROs need to adequately assess the safety data and document their reviews, the greater the opportunity for FDA to meet the performance goals set out in PDUFA and for FDA and industry together to deliver safe and effeectivenew therapies to US pat
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