Best Practices for Special Protocol Assessment
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Best Practices for Special Protocol Assessment
Linda Carter Johnson andJohnson, Rockville.Ma,.,,land Cathie Schrmoker AstraZeneca. Wilmington. Delaware
Key Words Special Protocol Assessment; SPA; Best practices
Correspondence Address Linda Carter, Senior Director Johnson and Johnson Pharmaceutical Research and Development, Rockville. M D 20852 (e-mail: LCarter2 @prdus.jnj.com).
The Special Protocol Assessment (SPA) process is a valuable mechanism for the Food and Drug Administration (FDA) to provide early feedback to sponsors on key development programs. Comprehensive review of pivotal studies designed to support regulatory approval has the potential to identify ._ key . study design issues eady in the drug developmentproc&s, facilitate sponsor-FDA discussion of key issues, and ensure that FDA and the sponsor are aligned and clear as to what the study needs to deliver in order to support approval.
BACKGROUND Prior to 1997 and the reauthorization of the Prescription Drug User Fee Act (PDUFA Ill) and enactment of the FDA Modernization Act, industry felt that the Food and Drug Administration (FDA) was providing a moving target rather than firm binding agreements with regard to data required in phase 3 studies to support approval. In 1997, the Food and Drug Administration Modernization Act (FDAMA) amended section 505(b) of the FD&C Act to new section 505(b)(4)(B) and (C). which provides that if a sponsor makes a reasonable written request to meet with the agency for the purpose of reaching agreement on the design and size of a clinical trial, the agency will meet with the sponsor. I f an agreement is reached, the agency will reduce the agreement to writing and make it part of the administrative record. The agreement will not be changed by the sponsor or FDA unless (1) the sponsor and FDA agree, or (2) if the director of the FDA reviewing division determines that "a substantial scientific issue essential to determining the safety or effectiveness of the drug" was identified after the testing began. The PDUFA goals were described in a letter dated November 12, 1997, from Donna Shalala. Secretary of Health and Human Services, to
Although the SPA process predates the Critical Path Initiative, it is consistent with FDA's goal of increasing transparency and facilitating efficient and effective drug development. FDA and industry expend significant resources in support of the SPA process. In order for the intended goals to be achieved, it is important that the process be applied consistenth be accomplished in a timely manne and allow for agreements to be documented in an eficient manna
Senator James Jeffords (1). The letter stated that the PDUFA goals for special protocol assessment and agreement provide that, upon request, FDA will evaluate certain protocols within 45 days and assess whether they are adequate to meet scientific and regulatory requirements identified by the sponsor. FDA published "Guidance for Industry-Specia1 Protocol Assessment" (SPA), dated May 2002. The guidance sets forth procedures "for request
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