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
Showing items related by title, author, creator and subject.
A Double-Blind, Placebo Controlled, Dose Ranging Study to Evaluate the Safety and Biological Efficacy of the Lipid-DNA Complex GR213487B in the Nasal Epithelium of Adult Patients with Cystic Fibrosis Knowles, Michael R.; Noone, Peadar G.; Hohneker, Kathy; Johnson, Larry G.; Boucher, Richard C.; Efthimiou, John; Crawford, Catriona; Brown, Ronan; Schwartzbach, Caryl; Pearlman, Rodney (1998-01-20)
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)