Purisol IS approved under the FDA's 505(b)(2) - U
Post# of 72435
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Under the FDA's 505(b)(2) regulatory pathway, a drug's road to market approval can be significantly shortened and at much reduced costs. Often only one pivotal Phase 3 study, enrolling a smaller number of patients than is typical, may be required. As well, the drug is eligible for up to five years of market exclusivity post-approval. For more information about the FDA's 505(b)(2) program, please visit:
http://www.fda.gov/downloads/Drugs/.../Guidan....pdf"
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