ALIGNMENT OF REGULATORY AND LIFECYCLE MANAGEMENT STRATEGIES FOR DRUGS SUBMITTED AS NEW DRUG APPLICATIONS UNDER 505(B)(2) OF THE FOOD, DRUG, AND COSMETIC ACT
VanHeusen, Margaret Ann
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Section 505(b)(2) of the Food, Drug, and Cosmetic Act (FDCA) (“505(b)(2)”), a component of the 1984 Hatch-Waxman Amendment allows the Food and Drug Administration (FDA) to rely on evidence not owned by the applicant. When combined with Section 115(a) of the Food and Drug Administration Modernization Act of 1997 (“Section 115(a)”), which allows for approvals to be based on one study and confirmatory evidence, clinical development programs can be streamlined, particularly during the 'Lifecycle' portion of the drug development program. This term is typically applied to the phase of development following the initial approval of the active moiety for products that often include modified-release or fixed-dose combination drugs. To further understand the strategies used in 505(b)(2) submissions, a database of informative variables describing the drug, applicant, and development program was created by abstracting information related to the development programs from publicly available Summary Basis of Approvals (SBOAs). Analyses were performed using descriptive statistics on the dataset as a whole, and by investigating intra-class differences, based on variables such as chemical and therapeutic classification. The findings from this study provide knowledge on critical points in development programs, and identify potential areas for improvement that may lead to an increase in efficiency for these processes.