Tag: Drugs and Devices

  • 21-U.S.C.-360H

    21-U.S.C.-360H §360H – Notification and Other Remedies Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 360h Details Reference: Section 360h Legend: §360H – Notification and Other Remedies USCode Year: 2013 Provision Content (a) Notification If the Secretary determines that— (1) a device intended for human use which is introduced or delivered for introduction into interstate commerce for…

  • 21-U.S.C.-360AA

    21-U.S.C.-360AA §360Aa – Recommendations For Investigations of Drugs For Rare Diseases Or Conditions Pathway Title 21 > Chapter 9 > Subchapter V > Part B > Section 360aa Details Reference: Section 360aa Legend: §360Aa – Recommendations For Investigations of Drugs For Rare Diseases Or Conditions USCode Year: 2013 Provision Content (a) Request by sponsor; response by Secretary The sponsor of a drug for…

  • 21-U.S.C.-360AA

    21-U.S.C.-360AA §360Aa – Recommendations For Investigations of Drugs For Rare Diseases Or Conditions Pathway Title 21 > Chapter 9 > Subchapter V > Part B > Section 360aa Details Reference: Section 360aa Legend: §360Aa – Recommendations For Investigations of Drugs For Rare Diseases Or Conditions USCode Year: 2013 Provision Content (a) Request by sponsor; response by Secretary The sponsor of a drug for…

  • 21-U.S.C.-360C

    21-U.S.C.-360C §360C – Classification of Devices Intended For Human Use Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 360c Details Reference: Section 360c Legend: §360C – Classification of Devices Intended For Human Use USCode Year: 2013 Provision Content (a) Classes of devices (1) There are established the following classes of devices intended for human use: (A) Class…

  • 21-U.S.C.-353A-1

    21-U.S.C.-353A-1 §353A-1 – §353A-1. Enhanced Communication Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 353a-1 Details Reference: Section 353a-1 Legend: §353A-1 – §353A-1. Enhanced Communication USCode Year: 2013 Provision Content (a) Submissions from State boards of pharmacy In a manner specified by the Secretary of Health and Human Services (referred to in this section as the Secretary),…

  • 21-U.S.C.-353A-1

    21-U.S.C.-353A-1 §353A-1 – §353A-1. Enhanced Communication Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 353a-1 Details Reference: Section 353a-1 Legend: §353A-1 – §353A-1. Enhanced Communication USCode Year: 2013 Provision Content (a) Submissions from State boards of pharmacy In a manner specified by the Secretary of Health and Human Services (referred to in this section as the Secretary),…

  • 21-U.S.C.-360C

    21-U.S.C.-360C §360C – Classification of Devices Intended For Human Use Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 360c Details Reference: Section 360c Legend: §360C – Classification of Devices Intended For Human Use USCode Year: 2013 Provision Content (a) Classes of devices (1) There are established the following classes of devices intended for human use: (A) Class…

  • 21-U.S.C.-360

    21-U.S.C.-360 §360 – Registration of Producers of Drugs Or Devices Pathway Title 21 > Chapter 9 > Subchapter V > Part A > Section 360 Details Reference: Section 360 Legend: §360 – Registration of Producers of Drugs Or Devices USCode Year: 2013 Provision Content (a) Definitions As used in this section— (1) the term manufacture, preparation, propagation, compounding, or processing shall include repackaging…

  • 21-U.S.C.-360BBB-1

    21-U.S.C.-360BBB-1 §360Bbb-1 – §360Bbb-1. Dispute Resolution Pathway Title 21 > Chapter 9 > Subchapter V > Part E > Section 360bbb-1 Details Reference: Section 360bbb-1 Legend: §360Bbb-1 – §360Bbb-1. Dispute Resolution USCode Year: 2013 Provision Content If, regarding an obligation concerning drugs or devices under this Act or section 351 of the Public Health Service Act [42 U.S.C. 262], there is a scientific…

  • 21-U.S.C.-360BBB-1

    21-U.S.C.-360BBB-1 §360Bbb-1 – §360Bbb-1. Dispute Resolution Pathway Title 21 > Chapter 9 > Subchapter V > Part E > Section 360bbb-1 Details Reference: Section 360bbb-1 Legend: §360Bbb-1 – §360Bbb-1. Dispute Resolution USCode Year: 2013 Provision Content If, regarding an obligation concerning drugs or devices under this Act or section 351 of the Public Health Service Act [42 U.S.C. 262], there is a scientific…