US FDA announces availability of ICH draft guidance on Clinical Studies E8(R1)
The U.S. FDA has announced the availability of a draft guidance entitled “E8(R1) General Considerations for Clinical Studies.” This describes internationally accepted principles and practices for the design and conduct of clinical studies of drug and biologic products. In addition, it 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 The draft guidance intends to promote the quality of the studies submitted to regulatory authorities, while allowing for flexibility.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.