USA – FDA draft guidance paves way for more real-world, point-of-care clinical trials
Year: 2024
Type: other
Abstract: The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance [Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice] that’s intended to pave the way for using data from research carried out during routine clinical practice to support drug approvals. FDA explained that during routine clinical practice, additional information is often gathered to support a wide range of purposes, for example in employment medical exams and trav...
Source: OpenEdition (OpenEdition)
DOI: 10.58079/12jhz
Author: Vroby
Language: English
Subfield: Statistics and Probability
Field: Mathematics
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W6899015831
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