This is fantastic. Particularly enthralled to read this:
"The major incentive afforded to a product with QIDP status is an additional 5 years of regulatory
exclusivity, on top of the standard regulatory exclusivity that comes with FDA approval of a New Drug
Application (NDA). This incentive could potentially enhance the value of a successful product as it
provides an extra 5 years of protection, during which period, generics cannot enter the market."
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- Ann: FDA Qualified Infectious Disease Product Status for BTX 1801
Ann: FDA Qualified Infectious Disease Product Status for BTX 1801, page-16
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