USA - FDA official clarifies misconceptions around RWE in premarket submissions
Year: 2024
Type: other
Abstract: Sponsors thinking of incorporating real-world evidence (RWE) into their submissions should consider RWE as just another form of clinical evidence, according to a recent presentation from a US Food and Drug Administration (FDA) official at the Orange County Regulatory Affairs Discussion Group annual conference. “[R]eal world evidence is just clinical evidence. There aren’t two things that we should be thinking about differently,” Felipe Aguel, deputy director in the Office of Clinical Evidenc...
Source: OpenEdition (OpenEdition)
DOI: 10.58079/12jhm
Author: Vroby
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W6899027040
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