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Volumn 23, Issue 3, 2004, Pages 277-280

Changes to the Hatch-Waxman Act following the "Medicare Prescription Drug, Improvement and Modernization Act of 2003"

(1)  Marenberg, Barry J a  

a NONE

Author keywords

[No Author keywords available]

Indexed keywords

BIOTECHNOLOGY; CONFIDENTIALITY; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; MEDICARE; PRESCRIPTION; REVIEW;

EID: 3242720290     PISSN: 0730031X     EISSN: None     Source Type: Journal    
DOI: 10.1089/0730031041370542     Document Type: Review
Times cited : (2)

References (17)
  • 2
    • 3242703491 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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on August 8, 2003, and which allows only one 30-month stay per product when litigation ensues over OB listed patents is superseded and has been revoked. 69 Fed.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on August 8, 2003, and which allows only one 30-month stay per product when litigation ensues over OB listed patents is superseded and has been revoked. 69 Fed.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 scopus 로고    scopus 로고
    • note
    • This is an indirect court decision trigger that remains from the old law.
  • 5
    • 3242662042 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1113
    • Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1113.
  • 11
    • 3242730620 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1112
    • Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1112.
  • 16
    • 3242704399 scopus 로고    scopus 로고
    • 69 Fed. Reg. 9982 (2004)
    • 69 Fed. Reg. 9982 (2004).
  • 17
    • 3242727070 scopus 로고    scopus 로고
    • 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).


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.