-
2
-
-
3242703491
-
-
Medicare Prescription Drug, Improvement and Modernization Act of 2003, PL 108-173, 2003 HR 1 21, amending U.S.C. 355(a), (b) and (j)
-
Medicare Prescription Drug, Improvement and Modernization Act of 2003, PL 108-173, 2003 HR 1 21, amending U.S.C. 355(a), (b) and (j).
-
-
-
-
3
-
-
3242716197
-
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, §§ 1101, 1102 (codified as amended at 21 U.S.C. 355(j)(2) and (5)). As a result of this provision in the Act, he FDA's regulation which became effective on August 8, 2003, and which allows only one 30-month stay per product when litigation ensues over OB listed patents is superseded and has been revoked. 69 Fed. Reg. 11309 (2004)
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, §§ 1101, 1102 (codified as amended at 21 U.S.C. 355(j)(2) and (5)). As a result of this provision in the Act, he FDA's regulation which became effective on August 8, 2003, and which allows only one 30-month stay per product when litigation ensues over OB listed patents is superseded and has been revoked. 69 Fed. Reg. 11309 (2004).
-
-
-
-
4
-
-
3242680951
-
-
note
-
This is an indirect court decision trigger that remains from the old law.
-
-
-
-
5
-
-
3242662042
-
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1102(a). Section 1102 of the ACT completely replaces Section 505(j)(5)(B)(iv)
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1102(a). Section 1102 of the ACT completely replaces Section 505(j)(5)(B)(iv).
-
-
-
-
6
-
-
3242672760
-
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1101(a)(2)(C)
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1101(a)(2)(C).
-
-
-
-
7
-
-
3242686521
-
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1101(a)(1)(B)(ii)
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1101(a)(1)(B)(ii).
-
-
-
-
8
-
-
3242674575
-
-
note
-
This reverses the FDA's regulation which did not require notice when a generic application with a Paragraph IV certification is amended to add an additional Paragraph IV certification.
-
-
-
-
9
-
-
3242690036
-
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1101(a)(1)(B)(2)(III)
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1101(a)(1)(B)(2)(III).
-
-
-
-
10
-
-
3242679247
-
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1113
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1113.
-
-
-
-
11
-
-
3242730620
-
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1101(c)(1)
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1101(c)(1).
-
-
-
-
12
-
-
3242706218
-
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1101(c)(2)
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1101(c)(2).
-
-
-
-
13
-
-
3242700810
-
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1101(c)(3)
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1101(c)(3).
-
-
-
-
14
-
-
3242660237
-
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1102(b)(1)
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1102(b)(1).
-
-
-
-
15
-
-
3242660238
-
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1112
-
Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1112.
-
-
-
-
16
-
-
3242704399
-
-
69 Fed. Reg. 9982 (2004)
-
69 Fed. Reg. 9982 (2004).
-
-
-
-
17
-
-
3242727070
-
-
69 Fed. Reg. 9982 (2004)
-
A Request for Comments was published in the Federal Register requesting submission from interested parties with regard to identifying issues contained in relevant portions of Title XI of the Act, along with suggestions for how to resolve those issues. The FDA would then consider the comments in assessing what regulatory actions might be appropriate. 69 Fed. Reg. 9982 (2004).
-
-
-
|