United States of America: Consultation closed on draft FDA guidance on digital health technologies in clinical investigations
Description
Consultation closed on draft FDA guidance on digital health technologies in clinical investigations
On 23 March 2022, the US Food and Drug Administration (FDA) closed its consultation on a draft guidance on the use of digital health technologies (DHTs), which are used to remotely acquire data about participants, in clinical trials. In providing gu…
Scope
Policy Area
Data governance
Policy Instrument
Data protection regulation
Regulated Economic Activity
cross-cutting
Implementation Level
national
Government Branch
executive
Government Body
other regulatory body