The controversy surrounding the repeal of the Amarin Vascepa SPA, coupled with the reported low probability of reaching a consensus with the FDA, could reduce the perceived value of such agreements. The FDA updated the SPA`s initial guidelines in May 2016 and responded to concerns about spa repeal by pointing out that less than 1% of the more than 1,000 SPA agreements concluded since the Food and Drug Modernization Act of 1997 (FDAMA) went into effect have been cancelled. The updated guidelines also clarify the FDA`s definition of a “critical scientific issue necessary for determining safety or efficacy” for which the FDA has the option of cancelling a SPA agreement. Among the specific examples of key scientific issues, the SPA is a process in which sponsors2 may request to meet with the FDA in order to reach agreement on the design and scope of certain clinical trials, clinical trials or animal studies3 (i.e. an application for an SPA (hereinafter referred to as the question); see Section III, Permitted Protocols and General Information), in order to determine whether they adequately meet the scientific and regulatory requirements of a study that may support the marketing authorisation. First, Phase 3 protocol design is one of the most challenging steps in any product development program and takes time and resources to be thoroughly completed. Answers to questions about the development of investigational drugs, such as .B. A minimum effective dose, an adequate subject population, and a clear and quantifiable definition of success in a Phase 2 program are extremely important to ensure that the primary clinical endpoint of your Phase 3 protocol design is properly identified and verified – clinically, scientifically, statistically, and regulatoryly. Failure to provide these details to the FDA in the SPA`s initial petition may lead to a failure of the spa process. Three types of protocols relating to PDUFA products are adapted to this specific assessment of the protocol as part of the objectives of the PDUFA: The FDA also has the option of cancelling a SPA agreement, although it is very rare and has been concluded in less than one percent of the more than 1,000 SPA agreements concluded by the Agency since 1997. It can occur when department heads or senior administrators find critical scientific safety or efficacy safety after the start of the study.
This could include: the guidelines that will finalize the Agency`s May 2016 draft set out the procedures for submitting a spa application, the content needed for such an application, the FDA`s assessment process, what will happen if the FDA and sponsor fail to reach an agreement on study protocols, and when changes can be made to the SPA agreements. SPA agreements have obvious advantages, but may not always be the most appropriate option. An SPA significantly reduces risk in the clinical trial design process by improving the overall predictability and safety of the drug development program. . . .