26 for an overview of the SPA program and a discussion of the impact of the FDAs new draft guidance on sponsors and regulatory affairs professionals, and key opportunities and challenges for sponsors. http://sandiegosunfire.com/medicalinterview/2016/09/04/suggestions-for-rational-osce-for-medical-solutions/FDAnews Falls Church, VA (PRWEB) September 29, 2016 Special Protocol Assessments: Decoding FDAs SPA Program and Revised Guidance **An FDAnews Webinar** How should manufacturers use SPAs to get feedback from the FDA on clinical trial design? How they can avoid getting a No Agreement Letter from the FDA after submitting a SPA? Join Alexander Varond Associate at Hyman, Phelps & McNamara on Oct. 26 for an overview of the SPA program and a discussion of the impact of the FDAs new draft guidance on sponsors and regulatory affairs professionals, and key opportunities and challenges for sponsors. After attending this 90-minute webinar manufacturers will: Understand how and when to optimally utilize SPAs to get feedback from the FDA on clinical trial design and maximize the chance that their trials will be successful. Determine the circumstances when FDA might rescind your SPA agreement. Address the critical issue of whether your SPAs will have an impact on the ability to market and promote products. Understand the deadlines established by FDA for submitting an SPA and how to avoid delays and lengthy negotiations in the process.i thought about this
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