Biotech Values

[biomaven0]

“presumption in favor policy”

I believe that only applies to complex mixtures where it is unclear whether the product contains a previously approved active moiety:

Generally, if the Agency has insufficient information to know whether a product contains a previously approved active moiety, the applicant would be required to submit an NDA containing substantial clinical safety and efficacy data. These data requirements could reasonably be expected to be comparable to those that would be needed for approval of an NCE. Under the presumption, if it is not known whether a product contains a previously approved active moiety, the product also would be treated as an NCE for marketing exclusivity purposes, and, accordingly, granted 5-year exclusivity.

See discussion at:

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/09/fda-applies-a-presumption-in-favor-of-nce-status-for-pancreatic-enzyme-products.html