Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Draft Guidance for Industry

Information

Type

Guidance

Regulated products

Biologics, Drugs, Medical Devices

Published

September 29, 2021

Last updated

September 29, 2021

Description

This document is a draft guidance for industry on investigator responsibilities for safety reporting of investigational drugs and devices.

Organization

Country / Region

United States

License

Other (Public Domain)

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