US Code

Tag: Drugs and Devices

  • 21-U.S.C.-360N-1

    21-U.S.C.-360N-1 §360N-1 – §360N-1. Priority Review For Qualified Infectious Disease Products Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 360n-1 Details Reference: Section 360n-1 Legend: §360N-1 – §360N-1. Priority Review For Qualified Infectious Disease Products USCode Year: 2013 Provision Content If the Secretary designates a drug under section 355f(d) of this title as a qualified infectious disease…

  • 21-U.S.C.-360N-1

    21-U.S.C.-360N-1 §360N-1 – §360N-1. Priority Review For Qualified Infectious Disease Products Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 360n-1 Details Reference: Section 360n-1 Legend: §360N-1 – §360N-1. Priority Review For Qualified Infectious Disease Products USCode Year: 2013 Provision Content If the Secretary designates a drug under section 355f(d) of this title as a qualified infectious disease…

  • 21-U.S.C.-355

    21-U.S.C.-355 §355 – New Drugs Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 355 Details Reference: Section 355 Legend: §355 – New Drugs USCode Year: 2013 Provision Content (a) Necessity of effective approval of application No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant…

  • 21-U.S.C.-360BBB-8B

    21-U.S.C.-360BBB-8B §360Bbb-8B – §360Bbb-8B. Use of Clinical Investigation Data From Outside The United States Pathway Title 21 > Chapter 9 > Subchapter V > Part E > Section 360bbb-8b Details Reference: Section 360bbb-8b Legend: §360Bbb-8B – §360Bbb-8B. Use of Clinical Investigation Data From Outside The United States USCode Year: 2013 Provision Content (a) In general In determining whether to approve, license, or clear…

  • 21-U.S.C.-355E

    21-U.S.C.-355E §355E – Pharmaceutical Security Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 355e Details Reference: Section 355e Legend: §355E – Pharmaceutical Security USCode Year: 2013 Provision Content (a) In general The Secretary shall develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated,…

  • Part E – General Provisions Relating To Drugs and Devices

    Part E – General Provisions Relating To Drugs and Devices General Provisions Relating To Drugs and Devices Pathway Title 21 > Chapter 9 > Subchapter V > Part E Details Reference: Part E Legend: General Provisions Relating To Drugs and Devices USCode Year: 2013 Provision Content U.S. Encyclopedia of Law Coverage Topic Map Title 21/Chapter 9/Subchapter V/Part E/Section 360bbb – §360Bbb…

  • Part E – General Provisions Relating To Drugs and Devices

    Part E – General Provisions Relating To Drugs and Devices General Provisions Relating To Drugs and Devices Pathway Title 21 > Chapter 9 > Subchapter V > Part E Details Reference: Part E Legend: General Provisions Relating To Drugs and Devices USCode Year: 2013 Provision Content U.S. Encyclopedia of Law Coverage Topic Map Title 21/Chapter 9/Subchapter V/Part E/Section 360bbb – §360Bbb…

  • Part H – Pharmaceutical Distribution Supply Chain

    Part H – Pharmaceutical Distribution Supply Chain Pharmaceutical Distribution Supply Chain Pathway Title 21 > Chapter 9 > Subchapter V > Part H Details Reference: Part H Legend: Pharmaceutical Distribution Supply Chain USCode Year: 2013 Provision Content U.S. Encyclopedia of Law Coverage 15-U.S.C.-4504 in the Legal Encyclopedia: Distribution In this entry about 15-U.S.C.-4504, find legal reference material, bibliographies and premiere content…

  • 21-U.S.C.-351

    21-U.S.C.-351 §351 – Adulterated Drugs and Devices Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 351 Details Reference: Section 351 Legend: §351 – Adulterated Drugs and Devices USCode Year: 2013 Provision Content A drug or device shall be deemed to be adulterated— (a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture (1) If it consists in whole…

  • 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…