US Code

Tag: Drugs and Devices

  • 21-U.S.C.-360A-1

    21-U.S.C.-360A-1 §360A-1 – §360A-1. Clinical Trials Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 360a-1 Details Reference: Section 360a-1 Legend: §360A-1 – §360A-1. Clinical Trials USCode Year: 2013 Provision Content (a) Review and revision of guidance documents (1) In general The Secretary of Health and Human Services (referred to in this section as the Secretary) shall review…

  • 21-U.S.C.-355A

    21-U.S.C.-355A §355A – Pediatric Studies of Drugs Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 355a Details Reference: Section 355a Legend: §355A – Pediatric Studies of Drugs USCode Year: 2013 Provision Content (a) Definitions As used in this section, the term pediatric studies or studies means at least one clinical investigation (that, at the Secretarys discretion, may…

  • Part B – Drugs For Rare Diseases Or Conditions

    Part B – Drugs For Rare Diseases Or Conditions Drugs For Rare Diseases Or Conditions Pathway Title 21 > Chapter 9 > Subchapter V > Part B Details Reference: Part B Legend: Drugs For Rare Diseases Or Conditions USCode Year: 2013 Provision Content U.S. Encyclopedia of Law Coverage Topic Map Title 21/Chapter 9/Subchapter V/Part B/Section 360aa – §360Aa – Recommendations For…

  • Part F – New Animal Drugs For Minor Use and Minor Species

    Part F – New Animal Drugs For Minor Use and Minor Species New Animal Drugs For Minor Use and Minor Species Pathway Title 21 > Chapter 9 > Subchapter V > Part F Details Reference: Part F Legend: New Animal Drugs For Minor Use and Minor Species USCode Year: 2013 Provision Content U.S. Encyclopedia of Law Coverage Topic Map Title 21/Chapter…

  • 21-U.S.C.-360L

    21-U.S.C.-360L §360L – §360L. Postmarket Surveillance Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 360l Details Reference: Section 360l Legend: §360L – §360L. Postmarket Surveillance USCode Year: 2013 Provision Content (a) Postmarket surveillance (1) In general (A) Conduct The Secretary may by order, at the time of approval or clearance of a device or at any time…

  • 21-U.S.C.-360OO

    21-U.S.C.-360OO §360Oo – §360Oo. Prohibited Acts Pathway Title 21 > Chapter 9 > Subchapter V > Part C > Section 360oo Details Reference: Section 360oo Legend: §360Oo – §360Oo. Prohibited Acts USCode Year: 2013 Provision Content (a) It shall be unlawful— (1) for any manufacturer to introduce, or to deliver for introduction, into commerce, or to import into the United States, any electronic…

  • 21-U.S.C.-360OO

    21-U.S.C.-360OO §360Oo – §360Oo. Prohibited Acts Pathway Title 21 > Chapter 9 > Subchapter V > Part C > Section 360oo Details Reference: Section 360oo Legend: §360Oo – §360Oo. Prohibited Acts USCode Year: 2013 Provision Content (a) It shall be unlawful— (1) for any manufacturer to introduce, or to deliver for introduction, into commerce, or to import into the United States, any electronic…

  • 21-U.S.C.-360CC

    21-U.S.C.-360CC §360Cc – Protection For Drugs For Rare Diseases Or Conditions Pathway Title 21 > Chapter 9 > Subchapter V > Part B > Section 360cc Details Reference: Section 360cc Legend: §360Cc – Protection For Drugs For Rare Diseases Or Conditions USCode Year: 2013 Provision Content (a) Exclusive approval, certification, or license Except as provided in subsection (b) of this section, if the…

  • 21-U.S.C.-360CC

    21-U.S.C.-360CC §360Cc – Protection For Drugs For Rare Diseases Or Conditions Pathway Title 21 > Chapter 9 > Subchapter V > Part B > Section 360cc Details Reference: Section 360cc Legend: §360Cc – Protection For Drugs For Rare Diseases Or Conditions USCode Year: 2013 Provision Content (a) Exclusive approval, certification, or license Except as provided in subsection (b) of this section, if the…

  • 21-U.S.C.-356D

    21-U.S.C.-356D §356D – Coordination; Task Force and Strategic Plan Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 356d Details Reference: Section 356d Legend: §356D – Coordination; Task Force and Strategic Plan USCode Year: 2013 Provision Content (a) Task force and strategic plan (1) In general (A) Task force As soon as practicable after July 9, 2012, the…