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References
1.
Public Law 110–85, Enacted 27th September, 2007 . 2. 21 U.S.C. § 360(n)(a)(3).
2.Id. at § 360(n)(a)(3)(Q).
3.
See 21 U.S.C. § 355 et seq. .
4.
21 U.S.C. § 360(n)(a)(4)(B).
5.
According to the statute, active ingredient includes any ester or salt of the active ingredient. See 21 U. S.C. § 360(n)(a)(4)(C).
6.
21 U.S.C. § 360(n)(a)(4)(C).
7.
21 U.S.C. § 360(n)(a)(2).
8.
21 U.S.C. § 360(n)(a)(1).
9.
21 U.S.C. § 360(n)(b)(2).
10.
21 U.S.C. § 360(n)(b)(3)(B).
11.Id. .
12.
The statute was enacted 27th September, 2007.
13.
21 U.S.C. § 360(n)(b)(3)(A).
14.
In 2002, Novartis founded the Novartis Institute for Tropical Diseases (‘NITD’). See Novartis Institute for Tropical Disease Website at http://www.nitd.novartis.com. Although the Novartis Institute predates the Tropical Disease Voucher Programme, other companies may follow suit with their own institutes given the incentives created by the voucher programme.
15.
Except for those few generic manufacturers that would be willing to continue or begin to file New Drug Applications.