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FDA considerations regarding new hypolipidemic agents
Author(s) -
Finkel Marion J.
Publication year - 1977
Publication title -
lipids
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.601
H-Index - 120
eISSN - 1558-9307
pISSN - 0024-4201
DOI - 10.1007/bf02532974
Subject(s) - medicine , food and drug administration , lipidology , postmarketing surveillance , drug , clinical trial , coronary artery disease , intensive care medicine , randomized controlled trial , pharmacology , reduction (mathematics) , clinical chemistry , adverse effect , geometry , mathematics
Food and Drug Administration policy being considered for new marketed hypolipidemic agents includes: long‐term safety to be demonstrated in postmarketing studies; evidence of clinical effectiveness to be demonstrated within a specified time period. Effectiveness is to be judged by one or more of the following: reduction in xanthomata, reduction in atherosclerotic plaque, reduction in morbidity of coronary artery disease or peripheral and cerebral atherosclerosis, and reduction in mortality. Randomized double blind trials are deemed necessary.