Pathway Under the FDA’s 505(b)(2) regulatory pa
Post# of 72440
Posted On: 05/26/2016 7:44:02 AM
Re: Loose Lips #23025
Pathway
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...079345.pdf
- See more at: http://cellceutix.com/cellceutix-provides-add...2ttAB.dpuf
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...079345.pdf
- See more at: http://cellceutix.com/cellceutix-provides-add...2ttAB.dpuf
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***On 02/26/2016 at 8:33 am Scottsmith admited to posting under 5 aliases but his post was subsequently deleted. I have a screen shot and will email it to anyone interested.
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