21 U.S.C. 355: New drugs

2022

• Pub. L. 117–328, §3209(a)(1)(A), substituted "nonclinical tests" for "preclinical tests (including tests on animals)". Law text · (i)
• Pub. L. 117–328, §3209(a)(1)(B), substituted "nonclinical tests" for "animal". Law text · (i)
• Pub. L. 117–328, §3222, added cl. (v). Law text · (j)
• Pub. L. 117–328, §3224, added cls. (i) to (iii) and struck out former cls. (i) to (iii) which read as follows: Law text · (j)
• Pub. L. 117–328, §3105(1), inserted "(other than bioavailability studies)" after "any clinical investigations". Law text · (u)
• Pub. L. 117–328, §3105(2), substituted "October 1, 2027" for "December 24, 2022". Law text · (u)
• Pub. L. 117–229 substituted "December 24, 2022" for "December 17, 2022". Law text · (u)
• Pub. L. 117–180 substituted "December 17" for "October 1". Law text · (u)
• Pub. L. 117–328, §3601(a), added subsec. (z) relating to diversity action plan for clinical studies. Law text · (z)
• Pub. L. 117–328, §3209(a)(2), added subsec. (z) defining nonclinical test. Law text · (z)

2021

• Pub. L. 116–290, §2(a)(1), amended par. (1) generally. Prior to amendment, par. (1) related to requirements for filing an application with respect to any drug subject to the provisions of subsec. (a). Law text · (b)
• Pub. L. 116–290, §2(b)(1), inserted at beginning "Not later than 30 days after the date of approval of an application submitted under subsection (b), the holder of the approved application shall file with the Secretary the patent number and the expiration date of any patent describe… Law text · (c)
• Pub. L. 117–9, §1(a)(1)(A), substituted "active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))" for "active ingredient (including any ester or salt of the active ingredient)" wherever appearing. Law text · (c)
• Pub. L. 116–290, §2(g)(1), substituted "subsection (b)(1)(A)(i)" for "clause (A) of subsection (b)(1)" wherever appearing. Law text · (c)
• Pub. L. 117–9, §1(b)(1)(A), struck out cl. (i) which read as follows: "If an application (other than an abbreviated new drug application) submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been ap… Law text · (c)
• Pub. L. 116–290, §2(g)(2), substituted "clauses (ii) through (vi) of subsection (b)(1)(A)" for "clauses (B) through (F) of subsection (b)(1)". Law text · (j)
• Pub. L. 117–9, §1(a)(1)(B), substituted "active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))" for "active ingredient (including any ester or salt of the active ingredient)" wherever appearing. Law text · (j)
• Pub. L. 117–9, §1(b)(1)(B), struck out cl. (i) which read as follows: "If an application (other than an abbreviated new drug application) submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been ap… Law text · (j)
• Pub. L. 116–290, §2(b)(2), struck out "(b) or" before "(c)". Law text · (j)
• Pub. L. 116–290, §2(c), added cl. (iv). Law text · (j)
• Pub. L. 116–290, §2(d)(1), added subpar. (D). Law text · (j)
• Pub. L. 117–9, §1(a)(1)(C)(i), amended cl. (i) generally. Prior to amendment, cl. (i) read as follows: "not later than 30 days after the date of approval of such application for a drug no active ingredient (including any ester or salt of the active ingredient) of which has bee… Law text · (l)
• Pub. L. 117–9, §1(a)(1)(C)(ii), inserted "or biological product" before period at end. Law text · (l)
• Pub. L. 117–9, §1(a)(1)(D), amended subsec. (s) generally. Prior to amendment, text read as follows: "Prior to the approval of a drug no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under this section or se… Law text · (s)
• Pub. L. 117–9, §1(a)(1)(E), in introductory provisions, substituted "active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))" for "active ingredient (including any ester or salt of the active ingredient)" a… Law text · (u)

2018

• Pub. L. 115–271, §3041(b)(1), substituted "safety or new effectiveness information" for "safety information" in heading and "If the Secretary becomes aware of new information, including any new safety information or information related to reduced effectiveness, that the Secretary… Law text · (o)
• Pub. L. 115–271, §3041(b)(2), inserted ", or new effectiveness information" after "adverse reactions". Law text · (o)
• Pub. L. 115–271, §3041(b)(3), substituted "safety or new effectiveness information" for "safety information". Law text · (o)
• Pub. L. 115–271, §3041(b)(4), substituted "safety or new effectiveness information" for "safety information". Law text · (o)

2017

• Pub. L. 115–52, §808(1), added cl. (v). Law text · (j)
• Pub. L. 115–52, §808(2), added cl. (iv). Law text · (j)
• Pub. L. 115–52, §801, added pars. (11) and (12). Law text · (j), (12)
• Pub. L. 115–52, §802, added par. (13). Law text · (j)
• Pub. L. 115–52, §901(a), made technical amendments to directory language of Pub. L. 114–255, §3075(a). See 2016 Amendment notes below. Law text · (k)
• Pub. L. 115–52, §601, substituted "2022" for "2017". Law text · (u)
• Pub. L. 115–52, §706(b), added subsec. (y). Law text · (y)

2016

• Pub. L. 114–255, §3031(a), added par. (5). Law text · (c)
• Pub. L. 114–255, §3101(a)(2)(B)(i), substituted "marketing approval" for "premarket approval" in last sentence. Law text · (d)
• Pub. L. 114–255, §3024(b), substituted "except where it is not feasible, it is contrary to the best interests of such human beings, or the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the … Law text · (i)
• Pub. L. 114–255, §3075(a)(1), as amended by Pub. L. 115–52, §901(a)(1), substituted "screenings" for ", bi-weekly screening". Law text · (k)
• Pub. L. 114–255, §3102(1)(A), inserted "and" after the semicolon. Law text · (k)
• Pub. L. 114–255, §3075(a)(2), as amended by Pub. L. 115–52, §901(a), substituted "; and" for period at end. Law text · (k)
• Pub. L. 114–255, §3102(1)(B), (C), redesignated subpar. (C) as (B) and struck out former subpar. (B) which read as follows: "report to Congress not later than 2 year after September 27, 2007, on procedures and processes of the Food and Drug Administration for addressing ongoing post market safety i… Law text · (k)
• Pub. L. 114–255, §3075(a)(3), as amended by Pub. L. 115–52, §901(a)(1), added subpar. (C). Law text · (k)
• Pub. L. 114–255, §3102(1)(C), redesignated subpar. (C) as (B). Law text · (k)
• Pub. L. 114–255, §3101(a)(2)(B)(ii), substituted "subsection (b)(2) or (j) of this section or section 262(k) of title 42" for "subsection (b)(2) or (j) of the Act or 262(k) of title 42". Law text · (q)
• Pub. L. 114–255, §3075(b), substituted "and making publicly available on the Internet website established under paragraph (1) best practices for drug safety surveillance activities for drugs approved under this section or section 262 of title 42" for ", by 18 months after approva… Law text · (r)

2015

• Pub. L. 114–89 added subsec. (x). Law text · (x)

2013

• Pub. L. 113–5 substituted "size—" for "size of clinical trials intended to form the primary basis of an effectiveness claim or, with respect to an applicant for approval of a biological product under section 262(k) of title 42, any necessary clinical study or studies.", added cls… Law text · (b)

2012

• Pub. L. 112–144, §905, inserted at end "The Secretary shall implement a structured risk-benefit assessment framework in the new drug approval process to facilitate the balanced consideration of benefits and risks, a consistent and systematic approach to the discussion and regulatory de… Law text · (d)
• Pub. L. 112–144, §1135(1)(A), substituted "subsection (b)(2) or (j) of this section or section 262(k) of title 42" for "subsection (b)(2) or (j)" in introductory provisions. Law text · (q)
• Pub. L. 112–144, §1135(1)(B), substituted "150 days" for "180 days" in introductory provisions. Law text · (q)
• Pub. L. 112–144, §1135(2)(A), substituted "150" for "180" in heading. Law text · (q)
• Pub. L. 112–144, §1135(2)(B), substituted "150-day" for "180-day". Law text · (q)
• Pub. L. 112–144, §1135(3), designated existing provisions as subpar. (A), redesignated former subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar. (A), and added subpar. (B). Law text · (q)
• Pub. L. 112–144, §1135(4), substituted "subsection (b)(2) or (j) of the Act or 262(k) of title 42" for "subsection (b)(2) or (j)". Law text · (q)
• Pub. L. 112–144, §1101(b), inserted "clinical" after "any". Law text · (u)
• Pub. L. 112–144, §1101(a), substituted "2017" for "2012". Law text · (u)
• Pub. L. 112–144, §1134(a), added subsec. (w). Law text · (w)

2010

• Pub. L. 111–148, §7002(d)(1), inserted "or, with respect to an applicant for approval of a biological product under section 262(k) of title 42, any necessary clinical study or studies" before period at end of first sentence. Law text · (b)
• Pub. L. 111–148, §10609, added par. (10). Law text · (j)

2009

• Pub. L. 111–31 made technical amendment to reference in original act which appears in text as reference to section 394 of this title. Law text · (n)

2008

• Pub. L. 110–316, §301, inserted concluding provisions. Law text · (q)
• Pub. L. 110–379 added subsec. (v). Law text · (v)

2007

• Pub. L. 110–85, §801(b)(3)(B), added par. (6). Law text · (b)
• Pub. L. 110–85, §903, inserted at end "The Secretary may withdraw the approval of an application submitted under this section, or suspend the approval of such an application, as provided under this subsection, without first ordering the applicant to submit an assessment of the approved… Law text · (e)
• Pub. L. 110–85, §801(b)(3)(A), inserted at end "The Secretary shall update such regulations to require inclusion in the informed consent documents and process a statement that clinical trial information for such clinical investigation has been or will be submitted for inclusion in t… Law text · (i)
• Pub. L. 110–85, §905(a), added pars. (3) and (4). Law text · (k), (4)
• Pub. L. 110–85, §921, added par. (5). Law text · (k)
• Pub. L. 110–85, §916, designated existing provisions as par. (1), redesignated former pars. (1) to (5) as subpars. (A) to (E), respectively, of par. (1), and added par. (2). Law text · (l)
• Pub. L. 110–85, §701(b), redesignated pars. (5) to (8) as (4) to (7), respectively, and struck out former par. (4) which read as follows: "Each member of a panel shall publicly disclose all conflicts of interest that member may have with the work to be undertaken by the panel… Law text · (n)
• Pub. L. 110–85, §901(a), added subsecs. (o) and (p). Law text · (o), (p)
• Pub. L. 110–85, §914(a), added subsec. (q). Law text · (q)
• Pub. L. 110–85, §915, added subsec. (r). Law text · (r)
• Pub. L. 110–85, §918, added subsec. (s). Law text · (s)
• Pub. L. 110–85, §920, added subsec. (t). Law text · (t)
• Pub. L. 110–85, §1113, added subsec. (u). Law text · (u)

2003

• Pub. L. 108–155, in second sentence, substituted "(F)" for "and (F)" and inserted ", and (G) any assessments required under section 355c of this title" before period at end. Law text · (b)
• Pub. L. 108–173, §1101(b)(1)(A), added par. (3) and struck out former par. (3) which, in subpar. (A), required an applicant making a certification under par. (2)(A)(iv) to include statement that applicant will give notice to each owner of the patent which is the subject of the certi… Law text · (b)
• Pub. L. 108–173, §1101(b)(1)(B), added par. (4) and redesignated former par. (4) as (5). Law text · (b), (5)
• Pub. L. 108–173, §1101(b)(2)(A), substituted "by applying the following to each certification made under subsection (b)(2)(A)" for "under the following" in introductory provisions. Law text · (c)
• Pub. L. 108–173, §1101(b)(2)(B)(iii), which directed the substitution of "subsection (b)(3)" for "paragraph (3)(B)" in third sentence, could not be executed because such words do not appear. See note below. Law text · (c)
• Pub. L. 108–173, §1101(b)(2)(B)(ii)(VI), in concluding provisions, struck out "Until the expiration of forty-five days from the date the notice made under paragraph (3)(B) is received, no action may be brought under section 2201 of title 28 for a declaratory judgment with respect to the patent. Any… Law text · (c)
• Pub. L. 108–173, §1101(b)(2)(B)(i), (ii)(I), in first sentence of introductory provisions, substituted "unless, before the expiration of 45 days after the date on which the notice described in subsection (b)(3) is received, an action is brought for infringement of the patent that is the subject of … Law text · (c)
• Pub. L. 108–173, §1101(b)(2)(B)(ii)(II), added cl. (i) and struck out former cl. (i) which read as follows: "if before the expiration of such period the court decides that such patent is invalid or not infringed, the approval may be made effective on the date of the court deci… Law text · (c)
• Pub. L. 108–173, §1101(b)(2)(B)(ii)(III), added cl. (ii) and struck out former cl. (ii) which read as follows: "if before the expiration of such period the court decides that such patent has been infringed, the approval may be made effective on such date as the court orders u… Law text · (c)
• Pub. L. 108–173, §1101(b)(2)(B)(ii)(IV), substituted "as provided in clause (i); or" for "on the date of such court decision." Law text · (c)
• Pub. L. 108–173, §1101(b)(2)(B)(ii)(V), added cl. (iv). Law text · (c)
• Pub. L. 108–173, §1101(b)(2)(C), (D), added subpar. (D) and redesignated former subpar. (D) as (E). Law text · (c), (E)
• Pub. L. 108–173, §1101(a)(1)(A), added subpar. (B) and struck out former subpar. (B) which, in cl. (i), required that an applicant making a certification under subpar. (A)(vii)(IV) include in the application a statement that notice would be given to each owner of the patent and t… Law text · (j)
• Pub. L. 108–173, §1101(a)(1)(B), added subpar. (D). Law text · (j)
• Pub. L. 108–173, §1101(a)(2)(A)(i), substituted "by applying the following to each certification made under paragraph (2)(A)(vii)" for "under the following" in introductory provisions. Law text · (j)
• Pub. L. 108–173, §1101(a)(2)(A)(ii)(II)(ee), which directed amendment of the second sentence of subsec. (j)(5)(B)(iii) by striking "Until the expiration" and all that follows in the matter after and below subclause (IV), was executed by striking "Until the expiration of fort… Law text · (j)
• Pub. L. 108–173, §1101(a)(2)(A)(ii)(I), in introductory provisions, substituted "unless, before the expiration of 45 days after the date on which the notice described in paragraph (2)(B) is received, an action is brought for infringement of the patent that is the subject of the certification and fo… Law text · (j)
• Pub. L. 108–173, §1101(a)(2)(A)(ii)(II)(aa), added subcl. (I) and struck out former subcl. (I) which read as follows: "if before the expiration of such period the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date … Law text · (j)
• Pub. L. 108–173, §1101(a)(2)(A)(ii)(II)(bb), added subcl. (II) and struck out former subcl. (II) which read as follows: "if before the expiration of such period the court decides that such patent has been infringed, the approval shall be made effective on such date as th… Law text · (j)
• Pub. L. 108–173, §1101(a)(2)(A)(ii)(II)(cc), substituted "as provided in subclause (I); or" for "on the date of such court decision." Law text · (j)
• Pub. L. 108–173, §1101(a)(2)(A)(ii)(II)(dd), added subcl. (IV). Law text · (j)
• Pub. L. 108–173, §1102(a)(1), added cl. (iv) and struck out former cl. (iv) which read as follows: "If the application contains a certification described in subclause (IV) of paragraph (2)(A)(vii) and is for a drug for which a previous application has been submitted under thi… Law text · (j)
• Pub. L. 108–173, §1101(a)(2)(B), (C), added subpar. (C). Former subpar. (C) redesignated (E). Law text · (j)
• Pub. L. 108–173, §1102(a)(2), added subpar. (D). Law text · (j)
• Pub. L. 108–173, §1101(a)(2)(B), redesignated subpar. (D) as (F). Law text · (j)
• Pub. L. 108–173, §1101(a)(2)(B), redesignated subpars. (C) and (D) as (E) and (F), respectively. Law text · (j), (F)
• Pub. L. 108–173, §1103(a)(1), added subpar. (A) and struck out former subpar. (A) which read as follows: "The term 'bioavailability' means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a drug and becomes available at the site of dru… Law text · (j)
• Pub. L. 108–173, §1103(a)(2), added subpar. (C). Law text · (j)

2002

• Pub. L. 107–109 added subpar. (D). Law text · (i)

1999

• Pub. L. 106–113 substituted "United States Patent and Trademark Office" for "Patent and Trademark Office of the Department of Commerce". Law text · (m)

1997

• Pub. L. 105–115, §115(b), inserted at end "The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities i… Law text · (b)
• Pub. L. 105–115, §119(a), added par. (4). Law text · (b)
• Pub. L. 105–115, §124(a), added par. (4). Law text · (c)
• Pub. L. 105–115, §115(a), inserted at end "If the Secretary determines, based on relevant science, that data from one adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or after such investigation) are sufficient to establish effectiveness,… Law text · (d)
• Pub. L. 105–115, §117, inserted "(1)" after "(i)", redesignated former pars. (1) to (3) as subpars. (A) to (C), respectively, of par. (1), added pars. (2) to (4), and struck out closing provisions which read as follows: "Such regulations shall provide that such exemption shall be condi… Law text · (i)
• Pub. L. 105–115, §119(b)(2)(A), substituted "paragraph (7)" for "paragraph (6)". Law text · (j)
• Pub. L. 105–115, §119(b)(1)(B), added par. (3). Former par. (3) redesignated (4). Law text · (j)
• Pub. L. 105–115, §119(b)(1)(A), (2)(B), redesignated par. (3) as (4) and in introductory provisions substituted "paragraph (5)" for "paragraph (4)". Former par. (4) redesignated (5). Law text · (j)
• Pub. L. 105–115, §119(b)(2)(C), substituted "paragraph (6)" for "paragraph (5)". Law text · (j)
• Pub. L. 105–115, §119(b)(1)(A), redesignated pars. (4) and (5) as (5) and (6), respectively. Former par. (6) redesignated (7). Law text · (j), (6)
• Pub. L. 105–115, §119(b)(1)(A), (2)(D), redesignated par. (6) as (7) and in subpar. (C) substituted "paragraph (6)" for "paragraph (5)" in two places. Former par. (7) redesignated (8). Law text · (j)
• Pub. L. 105–115, §119(b)(1)(A), redesignated pars. (7) and (8) as (8) and (9), respectively. Law text · (j), (9)
• Pub. L. 105–115, §120, added subsec. (n). Law text · (n)

1993

• Pub. L. 103–80, §3(n)(1)(A), substituted "Secretary" for "Secretry". · (j)
• Pub. L. 103–80, §3(n)(1)(B), inserted comma after "published by the Secretary". · (j)
• Pub. L. 103–80, §3(n)(2), substituted "section. Regulations" for "section: Provided, however, That regulations". · (k)

1992

• Pub. L. 102–282 added par. (8). · (j)

1984

• Pub. L. 98–417, §102(b)(1), inserted "or (j)" after "subsection (b)". · (a)
• Pub. L. 98–417, §§102(a)(1), 103(a), designated existing provisions of subsec. (b) as par. (1) thereof and redesignated existing cls. (1) through (6) of such par. (1) as cls. (A) through (F) thereof, respectively, inserted requirement that the applicant file with the application the pa… · (b)
• Pub. L. 98–417, §§102(a)(2), (b)(2), 103(b), designated existing provisions of subsec. (c) as par. (1) thereof and in par. (1) as so designated substituted "subsection (b)" for "this subsection" and redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, and added … · (c)
• Pub. L. 98–417, §102(a)(3)(A), added cl. (6) relating to the failure of the application to contain the patent information prescribed by subsec. (b) of this section, and redesignated former cl. (6) as (7). · (d), (7)
• Pub. L. 98–417, §102(a)(3)(B), in first sentence, added a new cl. (4) relating to the failure to file the patent information prescribed by subsec. (c) of this section within 30 days after the receipt of written notice from the Secretary specifying the failure to file such information, … · (e)
• Pub. L. 98–417, §102(b)(3), (4), in second sentence, inserted in provisions preceding cl. (1) "submitted under subsection (b) or (j)" and in cl. (1) substituted "under subsection (k) or to comply with the notice requirements of section 360(k)(2) of this title" for "under subsection (j) or to comply… · (e)
• Pub. L. 98–417, §101, added subsec. (j) and redesignated former subsec. (j) as (k). · (j), (k)
• Pub. L. 98–417, §102(b)(5), substituted "under subsection (b) or (j)" for "pursuant to this section". · (k)
• Pub. L. 98–417, §104, added subsecs. (l) and (m). · (l), (m)

1972

• Pub. L. 92–387 inserted "or to comply with the notice requirements of section 360(j)(2) of this title" in cl. (1) of second sentence relating to the maintenance of records. · (e)

1962

• Pub. L. 87–781, §104(a), inserted "an approval of" before "an application". · (a)
• Pub. L. 87–781, §102(b), inserted "and whether such drug is effective in use" after "is safe for use". · (b)
• Pub. L. 87–781, §104(b), substituted provisions requiring the Secretary, within 180 days after filing an application, or such additional period as the Secretary and the applicant agree upon, to either approve the application, if meeting the requirements of subsec. (d) of this section, … · (c)
• Pub. L. 87–781, §102(c), inserted references to subsec. (c), added cls. (5) and (6), provided that if after notice and opportunity for hearing, the Secretary finds that cls. (1) to (6) do not apply, he shall approve the application, and defined "substantial evidence" as used in this su… · (d)
• Pub. L. 87–781, §102(d), amended subsec. (e) generally, and among other changes, directed the Secretary to withdraw approval of an application if by tests, other scientific data or experience, or new evidence of clinical experience not contained in the application or available at the t… · (e)
• Pub. L. 87–781, §104(c), substituted provisions requiring the Secretary to revoke any previous order under subsecs. (d) or (e) of this section refusing, withdrawing, or suspending approval of an application and to approve such application or reinstate such approval, for provisions whic… · (f)
• Pub. L. 87–781, §104(d)(1), (2), inserted "as provided in section 2112 of title 28", and "except that until the filing of the record the Secretary may modify or set aside his order", substituted "or withdrawing approval of an application under this section" for "to permit the applicati… · (h)
• Pub. L. 87–781, §103(b), inserted "the foregoing subsections of" after "operation of", and "and effectiveness" after "safety", and provided that the regulations may condition exemptions upon the submission of reports of preclinical tests to justify the proposed clinical testing, upon t… · (i)
• Pub. L. 87–781, §103(a), added subsec. (j). · (j)

1960

• Pub. L. 86–507 inserted "or by certified mail" after "registered mail". · (g)