1. Has the FDA provided “sufficient guidance” to guide the development and registration of prescription diet drugs? If you agree, please provide examples of what you consider "sufficient advice" (including the date of publication). I believe the FDA provides sufficient guidance on the development and registration of prescription diet drugs. In 2007, the FDA released draft guidelines that clearly define expectations for judging effectiveness (weight reduction and maintenance of weight loss after 1 year of treatment). It also indicates that an effective product should provide improvements in blood pressure, lipids and blood sugar, therefore changes in common weight-related comorbidities must be taken into account in the clinical trial to evaluate effectiveness. The FDA also says it expects to see drug-mediated weight reduction demonstrated as a result of body fat loss verified through advanced screening tools. From a safety perspective, the FDA states that the drug is not expected to adversely affect cardiovascular function, particularly highlighting cardiac valvular disease.2. Have the FDA's reasons for rejecting NDAs of prescription diet pills over the past 10 years been based on safety/effectiveness concerns? In 2010 alone, three drugs reviewed by the Endocrinology and Metabolic Drugs Advisory Committee (EMDAC) failed to gain approval. The EMDAC considered that each drug (naltrexone/bupriopion, lorcaserin and phentermine/topiratate) had unacceptable safety concerns (in particular cardiovascular risk profiles). The committee also concluded that lorcaserin did not provide sufficiently convincing evidence of efficacy and safety to gain approval. EMDAC says the lack of diversity in the Phase 3 study population could result in an overestimation of the drug's effectiveness and an underestimation of potential safety risks. That... middle of the paper... FDA. (2010). FDA Information Document: NDA 22529 Lorqess (lorcaserin hydrochloride) tablets, 10 mg. Sponsor: Arena Pharmaceuticals Advisory Board. Retrieved from http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinlogicalandmetabolicdrugsadvisorycommittee/ucm225631.pdfFDA. (2007). Guide for the industry. Development of weight control products. Retrieved from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071612.pdfFDA. (2011). Predictive Safety Testing Consortium (PSTC). Retrieved from http://www.fda.gov/AboutFDA/PartnershipsCollaborations/PublicPrivatePartnershipProgram/ucm231132.htmlMcCallister, E. (2011). BioCentury, Obesity Reset. Retrieved from http://www.biocentury.com/promotions/obesity/next-generation-of-obesity-drugs-unlikely-to-reach-regulators-before-2014.html