21 U.S.C. 360cc: Protection for drugs for rare diseases or conditions

2020

• Pub. L. 116–260 added par. (3). (Consolidated Appropriations Act, 2021) Law text · (c)

2017

• Pub. L. 115–52, §607(a)(1), substituted "the same drug for the same disease or condition" for "such drug for such disease or condition" in concluding provisions. (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §607(a)(2)(A), in introductory provisions, substituted "During the 7-year period described in subsection (a) for an approved application under section 355 of this title or license under section 262 of title 42, the Secretary may approve an application or issue a license… (FDA Reauthorization Act of 2017) Law text · (b)
• Pub. L. 115–52, §607(a)(2)(B), substituted "of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure" for "notice and opportunity for the submission of views, that i… (FDA Reauthorization Act of 2017) Law text · (b)
• Pub. L. 115–52, §607(a)(2)(C), substituted "the holder provides" for "such holder provides". (FDA Reauthorization Act of 2017) Law text · (b)
• Pub. L. 115–52, §607(a)(3), added subsecs. (c) to (e). (FDA Reauthorization Act of 2017) Law text · (c), (d), (e)

2002

• Pub. L. 107–281, in concluding provisions, struck out ", of such certification," after "such approved application" and ", the issuance of the certification," after "approval of the approved application". (Rare Diseases Orphan Product Development Act of 2002) Law text · (a)

1997

• Pub. L. 105–115, §125(b)(2)(J), struck out ", issue another certification under section 357 of this title," before "or issue another license" in closing provisions, inserted "or" at end of par. (1), redesignated par. (3) as (2), and struck out former par. (2) which read as follows: "is… (Food and Drug Administration Modernization Act of 1997) Law text · (a)
• Pub. L. 105–115, §125(b)(2)(K), in introductory provisions, struck out ", if a certification is issued under section 357 of this title for such a drug," after "rare disease or condition", ", of the issuance of the certification under section 357 of this title," after "application appro… (Food and Drug Administration Modernization Act of 1997) Law text · (b)
• Pub. L. 105–115, §125(b)(2)(K), struck out ", of the certification," after "holder of the approved application". (Food and Drug Administration Modernization Act of 1997) Law text · (b)
• Pub. L. 105–115, §125(b)(2)(K), struck out ", issuance of other certifications," after "approval of other applications". (Food and Drug Administration Modernization Act of 1997) Law text · (b)

1993

• Pub. L. 103–80 struck out extraneous comma before "or issue a license under section 262" in introductory provisions and substituted "the" for "The" at beginning of par. (1). · (b)

1985

• Pub. L. 99–91, §2(3), struck out "unpatented" before "drugs" in section catchline.
• Pub. L. 99–91, §§2(1), 3(a)(3)(A)–(D), struck out "or" at end of par. (1), added par. (2), redesignated former par. (2) as (3), struck out "and for which a United States Letter of Patent may not be issued" after "rare disease or condition", inserted in first sentence ", issue another c… · (a)
• Pub. L. 99–91, §§2(2), 3(a)(3)(E)–(K), struck out "and if a United States Letter of Patent may not be issued for the drug" after "such a drug", substituted ", if a certification is issued under section 357 of this title for such a drug, or if a license" for "or a license", inserted ", … · (b)

1984

• Pub. L. 98–417 substituted "section 355" for "section 355(b)" wherever appearing. · (a), (b)