In determining whether to approve, license, or clear a drug, biological product, or
device pursuant to an application submitted under this subchapter, the Secretary shall
accept data from clinical investigations conducted outside of the United States, including
the European Union, if the applicant demonstrates that such data are adequate under
applicable standards to support approval, licensure, or clearance of the drug, biological
product, or device in the United States.
(b)Notice to sponsor
If the Secretary finds under subsection (a) that the data from clinical investigations
conducted outside the United States, including in the European Union, are inadequate
for the purpose of making a determination on approval, clearance, or licensure of
a drug, biological product, or device pursuant to an application submitted under this
subchapter, the Secretary shall provide written notice to the sponsor of the application
of such finding and include the rationale for such finding.
FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature or via Westlaw before relying on it for your legal needs.
Was this helpful?
Welcome to FindLaw's Cases & Codes
A free source of state and federal court opinions, state laws, and the United States Code. For more information about the legal concepts addressed by these cases and statutes, visit FindLaw's Learn About the Law.