Prescription Obesity Drugs Essay -- Pharmaceuticals

1.Has FDA abided sufficient guidance to guide development and registration of prescription drug drug drug fare medications? If you agree, propose examples of what you consider sufficient advice (including date of publication). I mean the FDA does provide sufficient guidance on the development and registration of prescription forage medications. In 2007, FDA issued draft guidance that clearly defines their expectations to judge effectuality (weight drop-off and maintenance of weight harm after 1 stratums treatment). It also indicates an effective product should provide improvements in melodic line pressure, lipids, and glycaemia and so changes in common weight-related comorbidities need factored into clinical outpouring to esteem efficacy. FDA also states it expects to see drug-mediated weight reduction demonstrated to result from a loss of body fat verified through advance covering fire tools. From a sanctuary perspective, the FDA states the drug should not adversely affect cardiovascular break down particularly highlighting cardiac valvulopathy. 2.Has FDAs grounds for rejecting the NDAs of prescription diet pills in the last 10 years been based on resort/efficacy concerns? In 2010 alone, three drugs reviewed by the Endocrinologic and Metabolic Drugs consultive direction (EMDAC) have failed to pull approval. EMDAC felt each drug (naltrexone/bupriopion, lorcaserin and phentermine/topiratate) had impossible safety issues (particularly cardiovascular risk profiles). The committee also concluded that lorcaserin did not provide enough convincing evidence of efficacy and safety to gain approval. EMDAC name lack of diversity in the phase 3 trial people might result in efficacy of the drug beingness enlarged while potential safety risks understated. Whi... ...FDA. (2010). FDA Briefing Document NDA 22529 Lorqess (lorcaserin hydrochloride) Tablets, 10 mg. denounce Arena Pharmaceuticals Advisory Committee. Retrieved from http//www.fda.gov/downl oads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinlogicalandmetabolicdrugsadvisorycommittee/ucm225631.pdfFDA. (2007). Guidance for Industry. Developing Products for Weight Management. Retrieved from http//www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071612.pdf FDA. (2011).Predictive sentry duty examination Consortium (PSTC). Retrieved from http//www.fda.gov/AboutFDA/PartnershipsCollaborations/PublicPrivatePartnershipProgram/ucm231132.html McCallister, 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 Prescription Obesity Drugs search -- Pharmaceuticals1.Has FDA provided sufficient guidance to guide development and registration of prescription diet medications? If you agree, provide examples of what you consider sufficient advice (including date of publication). I believe the FDA does provi de sufficient guidance on the development and registration of prescription diet medications. In 2007, FDA issued draft guidance that clearly defines their expectations to judge effectiveness (weight reduction and maintenance of weight loss after 1 years treatment). It also indicates an effective product should provide improvements in blood pressure, lipids, and glycaemia therefore changes in common weight-related comorbidities need factored into clinical trial to assess efficacy. FDA also states it expects to see drug-mediated weight reduction demonstrated to result from a loss of body fat verified through advance screening tools. From a safety perspective, the FDA states the drug should not adversely affect cardiovascular function particularly highlighting cardiac valvulopathy. 2.Has FDAs grounds for rejecting the NDAs of prescription diet pills in the last 10 years been based on safety/efficacy concerns? In 2010 alone, three drugs reviewed by the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) have failed to gain approval. EMDAC felt each drug (naltrexone/bupriopion, lorcaserin and phentermine/topiratate) had unacceptable safety issues (particularly cardiovascular risk profiles). The committee also concluded that lorcaserin did not provide enough convincing evidence of efficacy and safety to gain approval. EMDAC cite lack of diversity in the phase 3 trial population might result in efficacy of the drug being overstated while potential safety risks understated. Whi... ...FDA. (2010). FDA Briefing Document NDA 22529 Lorqess (lorcaserin hydrochloride) Tablets, 10 mg. Sponsor Arena Pharmaceuticals Advisory Committee. Retrieved from http//www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinlogicalandmetabolicdrugsadvisorycommittee/ucm225631.pdfFDA. (2007). Guidance for Industry. Developing Products for Weight Management. Retrieved from http//www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ ucm071612.pdf FDA. (2011).Predictive Safety Testing Consortium (PSTC). Retrieved from http//www.fda.gov/AboutFDA/PartnershipsCollaborations/PublicPrivatePartnershipProgram/ucm231132.html McCallister, 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