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Federal "right-to-try" legislation : legal considerations

Staman, Jennifer A., author.
[Washington, D.C.] : Congressional Research Service, 2018- 2018

Guidance for industry considerations for developmental toxicity studies for preventive and therapeut

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2006] 2006

Guidance for industry IND exemptions for studies of lawfully marketed drug or biological products fo

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2004] 2004

Guidance for industry IND meetings for human drugs and biologics, chemistry, manufacturing, and cont

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2001] 2001

Guidance for industry INDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls i

[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2003] 2003