The FDA's regulatory framework not only provides competitive advantages for authorized products but also creates barriers for new entrants, particularly those lacking regulatory expertise or the financial resources for extensive approval processes
Note that the analyses could have been based on a single large model, with planned contrasts, but we found the present pairwise approach more transparent, and the separate models are also less restrictive than a full model
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Graham, Jerrold Freedman, Joe Napolitano, Kevin Hooks, Larry Shaw, Richard Compton, Tucker Gates, Allen Coulter, Barry K