Zdrowie i gospodarka · 20/12/2012
Guidances for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies, and a Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA) has released two guidances to aid industry and investigators in meeting safety reporting requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies. The Small Entity Compliance Guide is designed to assist small businesses in complying with FDA regulations.
Source: Federal Register — Food and Drug AdministrationOpen original release →