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Biotech / Medical : ProMetic Life Sciences -- Ignore unavailable to you. Want to Upgrade?

To: axial who wrote (118)	8/29/2017 7:00:57 AM
From: axial	Respond to of 250

What Other Types of Vouchers Exist? ' So far, two other types of voucher exists: rare pediatric disease priority review voucher and medical countermeasure priority review vouchers. The rare pediatric voucher was created in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA), and specifically targets the need for additional therapies for rare pediatric subsets of other diseases. Section 908 of FDASIA defines a "rare pediatric disease" as one which "primarily affects individuals aged from birth to 18 years, including age groups often called neonates, infants, children and adolescents," and is a rare disease according to federal statute (200,000 persons in the US or fewer). The rare pediatric voucher system is closely modeled off the tropical disease voucher system, with several exceptions. Perhaps the most notable difference at the time of the pediatric voucher's initial passing was its relative ease of use. Unlike the tropical voucher, which required FDA to be notified 365 days prior to its use, the rare pediatric voucher could be used just 90 days prior to its use. Another key difference: The rare pediatric voucher could be transferred (i.e. sold) an unlimited number of times, unlike the tropical disease voucher which could only be sold once. However, as of December 2014, both of these differences have been erased under the Adding Ebola to the FDA Priority Review Voucher Program Act, which eliminated the disparity between the two vouchers. Tropical vouchers may now be redeemed in just 90 days, and may be resold an unlimited number of times. In 2016, the 21st Century Cures Act was signed into law creating a priority review voucher program for medical countermeasures, though to date no product has been awarded a priority review voucher under the program.' Jim