One page per section. Assumptions The central assumption for FDA approval is the

One page per section.
Assumptions
The central assumption for FDA approval is the politics
involved. It would seem that knowing someone in the U.S. government or hiring a
good lobbyist can provide a more streamlined application process.
Limitations
A limitation of this study is the sensitivity of the data
needed for validation. There are many regulations in place as to how a
pharmaceutical company can disseminate new information. The companies contacted
would be wary of providing information that could potentially delay FDA
applications. They also risk being fined by the Securities Exchange Commission
(SEC).
Delimitations
To overcome the limitations, a study will adjust the
scope to request only pertinent information carefully. The questions asked will
not include data linking specific drugs or companies.