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Fairness in Orphan Drug Exclusivity Act : report (to accompany H.R. 4712).

United States. Congress. House. Committee on Energy and Commerce, author.
[Washington, D.C.] : [U.S. Government Publishing Office], [2020] 2020

Food and Drug Administration's review process for products to treat rare diseases and neglected trop

United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies.
Washington : U.S. G.P.O., 2011. 2011

Guidance for industry interpreting sameness of monoclonal antibody products under the orphan drug re

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drugs Evaluation and Research, [1999] 1999