BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 01/10/2019

Patient-Focused Drug Development: Methods To Identify What Is Important to Patients; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, FDA staff, and other stakeholders entitled "Patient-Focused Drug Development: Methods To Identify What Is Important to Patients." This guidance (Guidance 2) is the second in a series of four methodological guidance documents that FDA committed to develop to describe how to collect and submit information from patients and caregivers to be used for medical product development and regulatory decision-making.

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