Assessing the benefit-risk for new drugs: Are the FDA's endocrinologic and metabolic drugs advisory committee and the division of metabolism and endocrinology products in sync?
DECISION MAKING;
DRUG APPROVAL;
DRUG LABELING;
DRUG MARKETING;
DRUG SAFETY;
ENDOCRINOLOGY;
FOOD AND DRUG ADMINISTRATION;
HUMAN;
METABOLISM;
NOTE;
ORGANIZATION AND MANAGEMENT;
RISK BENEFIT ANALYSIS;
ADVISORY COMMITTEES;
DRUG APPROVAL;
HUMANS;
RISK ASSESSMENT;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
U.S. Food and Drug Administration. Advisory Committees: Laws, Regulation & Guidance [online], 2012. Available from http:// www.fda.gov/ AdvisoryCommittees/AboutAdvisoryCommittees/ LawsRegulationsGuidance/ default.htm. Accessed 13 March 2013
U.S. Food and Drug Administration. Advisory Committees: Endocrinologic and Metabolic Drugs Advisory Committee [online], 2013. Available from http://www.fda.gov/ AdvisoryCommittees/CommitteesMeeting- Materials/Drugs/ EndocrinologicandMetabolicDrugsAdvisoryCommittee/ default.htm. Accessed 13 March 2013
A quantitative approach to benefit-risk assessment of medicines - Part 1: The development of a new model using multi-criteria decision analysis
Mussen F, Salek S, Walker S. A quantitative approach to benefit-risk assessment of medicines - part 1: the development of a new model using multi-criteria decision analysis. Pharmacoepidemiol Drug Saf 2007;16(Suppl. 1):S2-S15
Application of the BRAT framework to case studies: Observations and insights
Levitan BS, Andrews EB, Gilsenan A, et al. Application of the BRAT framework to case studies: observations and insights. Clin Pharmacol Ther 2011;89:217-224
Development of a framework for enhancing the transparency, reproducibility and communication of the benefitrisk balance of medicines
Coplan PM, Noel RA, Levitan BS, Ferguson J, Mussen F. Development of a framework for enhancing the transparency, reproducibility and communication of the benefitrisk balance of medicines. Clin Pharmacol Ther 2011;89:312-315
Improving the decision-making process for nonprescription drugs: A framework for benefitrisk assessment
Brass EP, Lofstedt R, Renn O. Improving the decision-making process for nonprescription drugs: a framework for benefitrisk assessment. Clin Pharmacol Ther 2011;90:791-803
Silver Spring Maryland, April 2 2009, Accessed 17 April 2013
U.S. Food and Drug Administration. Endocrinologic and Metabolic Drugs Advisory Committee Meeting (official transcript), Silver Spring, Maryland, April 2, 2009 [online], 2009. Available from http://www. fda.gov/downloads/ AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ EndocrinologicandMetabolicDrugsAdvisory- Committee/UCM151176.pdf. Accessed 17 April 2013
