BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 30/09/2021

FDA Releases Draft Guidance on Investigator Responsibilities for Safety Reporting of Investigational Drugs and Devices

The FDA has published a draft guidance to help clinical investigators comply with safety reporting requirements for IND and IDE studies, focusing on identifying and reporting unanticipated safety issues related to investigational drugs and devices.

Source: Federal Register — Food and Drug AdministrationOpen original release →