FDA Disclosure of Safety and Efficacy Data: The Scope of Section 301(j)
Fortunato, Richard S.
FORDHAM LAW REVIEW 52(6): 1280-1299, May 1984
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The role of animal models in evaluating reasonable safety and efficacy for human trials of cell-based interventions for neurologic conditions. Regenberg, Alan; Mathews, Debra J.H.; Blass, David M.; Bok, Hilary; Coyle, Joseph T.; Duggan, Patrick; Faden, Ruth; Finkel, Julia; Gearhart, John D.; Hillis, Argye; Hoke, Ahmet; Johnson, Richard; Johnston, Michael; Kahn, Jeffrey; Kerr, Douglas; King, Patri (2009-01)