USA – FDA releases draft guidance on use-related risk analysis for combo products
Year: 2024
Type: other
Abstract: The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for drug- and biologic-led combination products. The URRA draft guidance is relevant for drug- and biologic-led combination products, as well as human nonprescription drug products that are part of an investigational new drug application (IND), a new drug application (NDA), or a biologics license application (BLA) or supplements to IND, NDA, or BLA a...
Source: OpenEdition (OpenEdition)
DOI: 10.58079/12jag
Author: Vroby
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6898955900
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