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Early years saw limited testing

Thus, we believe that requiring applicants to have already submitted a market authorization request to FDA at the time of submission of the new technology add-on payment application would further increase transparency and improve the evaluation process, including the identification of critical questions in the proposed rule, particularly as the number and complexity of the applications have been increasing over time

Sources Haufroid, V., Lauwerys, R

What Would Warrant Stopping and Why the Usual Framework Doesn't Apply For trial-backed peptides, this is where documented discontinuation criteria from clinical protocols would go