Posted On: 05/29/2016 12:15:23 AM
Post# of 72447
Purisol IS approved under the FDA's 505(b)(2) -
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"
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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If you try to defend yourself against lies of the board moderators your post will be deleted. Just like the board they claim to be better than!!! Watch who you trust especially the "long term investors" that support the real attackers!
