Tag: Drugs and Devices

  • 21-U.S.C.-355-1

    21-U.S.C.-355-1 §355-1 – §355-1. Risk Evaluation and Mitigation Strategies Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 355-1 Details Reference: Section 355-1 Legend: §355-1 – §355-1. Risk Evaluation and Mitigation Strategies USCode Year: 2013 Provision Content (a) Submission of proposed strategy (1) Initial approval If the Secretary, in consultation with the office responsible for reviewing the drug…

  • 21-U.S.C.-355-1

    21-U.S.C.-355-1 §355-1 – §355-1. Risk Evaluation and Mitigation Strategies Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 355-1 Details Reference: Section 355-1 Legend: §355-1 – §355-1. Risk Evaluation and Mitigation Strategies USCode Year: 2013 Provision Content (a) Submission of proposed strategy (1) Initial approval If the Secretary, in consultation with the office responsible for reviewing the drug…

  • 21-U.S.C.-356E

    21-U.S.C.-356E §356E – Drug Shortage List Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 356e Details Reference: Section 356e Legend: §356E – Drug Shortage List USCode Year: 2013 Provision Content (a) Establishment The Secretary shall maintain an up-to-date list of drugs that are determined by the Secretary to be in shortage in the United States. (b) Contents…

  • 21-U.S.C.-360JJ

    21-U.S.C.-360JJ §360Jj – Studies By Secretary Pathway Title 21 > Chapter 9 > Subchapter V > Part C > Section 360jj Details Reference: Section 360jj Legend: §360Jj – Studies By Secretary USCode Year: 2013 Provision Content (a) Report to Congress The Secretary shall conduct the following studies, and shall make a report or reports of the results of such studies to the Congress…

  • 21-U.S.C.-360KK

    21-U.S.C.-360KK §360Kk – Performance Standards For Electronic Products Pathway Title 21 > Chapter 9 > Subchapter V > Part C > Section 360kk Details Reference: Section 360kk Legend: §360Kk – Performance Standards For Electronic Products USCode Year: 2013 Provision Content (a) Promulgation of regulations (1) The Secretary shall by regulation prescribe performance standards for electronic products to control the emission of electronic product…

  • 21-U.S.C.-360KK

    21-U.S.C.-360KK §360Kk – Performance Standards For Electronic Products Pathway Title 21 > Chapter 9 > Subchapter V > Part C > Section 360kk Details Reference: Section 360kk Legend: §360Kk – Performance Standards For Electronic Products USCode Year: 2013 Provision Content (a) Promulgation of regulations (1) The Secretary shall by regulation prescribe performance standards for electronic products to control the emission of electronic product…

  • 21-U.S.C.-360EEE-3

    21-U.S.C.-360EEE-3 §360Eee-3 – §360Eee-3. National Standards For Third-Party Logistics Providers Pathway Title 21 > Chapter 9 > Subchapter V > Part H > Section 360eee-3 Details Reference: Section 360eee-3 Legend: §360Eee-3 – §360Eee-3. National Standards For Third-Party Logistics Providers USCode Year: 2013 Provision Content (a) Requirements No third-party logistics provider in any State may conduct activities in any State unless each facility of…

  • 21-U.S.C.-360BBB-8

    21-U.S.C.-360BBB-8 §360Bbb-8 – §360Bbb-8. Consultation With External Experts On Rare Diseases, Targeted Therapies, and Genetic Targeting of Treatments Pathway Title 21 > Chapter 9 > Subchapter V > Part E > Section 360bbb-8 Details Reference: Section 360bbb-8 Legend: §360Bbb-8 – §360Bbb-8. Consultation With External Experts On Rare Diseases, Targeted Therapies, and Genetic Targeting of Treatments USCode Year: 2013 Provision Content (a) In general…

  • 21-U.S.C.-360EEE-1

    21-U.S.C.-360EEE-1 §360Eee-1 – §360Eee-1. Requirements Pathway Title 21 > Chapter 9 > Subchapter V > Part H > Section 360eee-1 Details Reference: Section 360eee-1 Legend: §360Eee-1 – §360Eee-1. Requirements USCode Year: 2013 Provision Content (a) In general (1) Other activities Each manufacturer, repackager, wholesale distributor, and dispenser shall comply with the requirements set forth in this section with respect to the role of…

  • 21-U.S.C.-355F

    21-U.S.C.-355F §355F – Extension of Exclusivity Period For New Qualified Infectious Disease Products Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 355f Details Reference: Section 355f Legend: §355F – Extension of Exclusivity Period For New Qualified Infectious Disease Products USCode Year: 2013 Provision Content (a) Extension If the Secretary approves an application pursuant to section 355 of…