BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 13/06/2018

Patient-Focused Drug Development: Collecting Comprehensive and Representative Input; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, FDA staff, and other stakeholders entitled "Patient-Focused Drug Development: Collecting Comprehensive and Representative Input." This guidance (Guidance 1) is the first of a series of four methodological guidance documents that FDA committed to develop to address in a stepwise manner how to collect and submit information from patients and caregivers for medical product development and regulatory decision making.

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