n25) Idea-to-new medicine road - Full
Development phase
nIn this Full Development stage, known as Phase lll,
several thousand
patients with the particular disease receive the drug in carefully controlled studies
to test its safety, tolerability, and efficacy. Finally, if the compound has proved its
worth in all these tests, it enters the Registration phase in which the data of its entire history
are compiled and analyzed in a regulatory submission. This New Drug Application, or NDA, is
submitted to
the FDA for review. In parallel, a
Marketing Authorization Application (MAA) is filed in Europe, followed by a Japanese NDA. Only after a
successful regulatory review does the candidate become a new
medicine.
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