FDA Protocol deviations for clinical investigations of drugs, biological products, and devices (from Catapult's regulatory round-up for December 2024)
Year: 2025
Type: other
Abstract: FDA has issued a draft guidance which provides recommendations to assist sponsors, clinical investigators, and institutional review boards (IRBs) in defining, identifying, and reporting protocol deviations in clinical investigations. This guidance includes the following: Definitions for protocol deviations and important protocol deviations Recommendations on the types of protocol deviations that sponsors should report to FDA in clinical study reports for drugs and devices Recommendations on ...
Source: Hypotheses (OpenEdition)
DOI: 10.58079/13ay2
Author: Adelage
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6955145784
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