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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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