The Food and Drug Administration is announcing the availability of the following final guidances:
- E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1) - This guidance amends the guidance entitled “E6 Good Clinical Practice: Consolidated Guidance (E6(R1))” to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also updates standards regarding electronic records and essential documents. The guidance is intended to improve clinical trial quality and efficiency, while maintaining human subject protection and reliability of trial results;
- E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population - This guidance is an addendum to the ICH E11 guidance published in 2000 and is intended to provide high level guidance on the implementation of important approaches in pediatric drug development;
- E18 Genomic Sampling and Management of Genomic Data - intended to provide harmonized principles of genomic sampling and of management of genomic data in clinical studies to foster interactions amongst stakeholders, including drug developers, investigators, and regulators; and to encourage genomic research within clinical studies and
- M7(R1): Assessment and Control of Deoxyribonucleic Acid Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk – provides guidance on acceptable intake limits derived for some chemicals that are considered to be mutagenic carcinogens and are also commonly used in the synthesis of pharmaceuticals.
The guidances were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). FDA publishes ICH guidelines as FDA guidances.
Guidances reflect just one element in FDA’s work with regulatory authorities and industry associations from around the world to promote international harmonization of regulatory requirements under the ICH. One of the goals of harmonization is to identify and reduce differences in technical requirements for drug development among regulatory agencies. FDA is committed to seeking scientifically based harmonized technical procedures for the development and manufacture of pharmaceuticals.