FDA Publication of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines | FDA

E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES | FDA

The U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled “E8(R1) General Considerations for Clinical Studies.” The draft guidance, was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and  describes internationally accepted principles and practices for the design and conduct of clinical studies of drug and biologic products.  In addition, the draft guidance provides an overview of the types of clinical studies that sponsors may perform and data sources they may use during the product’s life cycle. The draft guidance intends to promote the quality of the studies submitted to regulatory authorities, while allowing for flexibility. Interested parties may submit comments to the docket under docket number FDA-2019-D-3049.

This guidance reflects just one element in the FDA’s work with regulatory authorities and industry associations from around the world to promote international harmonization of regulatory requirements under the ICH. The FDA publishes all ICH guidelines as FDA guidances. One of the goals of harmonization is to identify and reduce differences in technical requirements for drug development among regulatory agencies. The FDA is committed to seeking scientifically based harmonized technical procedures for drug development and manufacturing.