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# 4 ICH Guidances Announced
- URL: https://www.fdaweb.com/4-ich-guidances-announced/
- Published: 2018-04-11T12:00:00.000Z
- Updated: 2026-09-14T23:58:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141196

FDA has announced availability of four [guidances](http://s2027422842.t.en25.com/e/es?s=2027422842&e=73810&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=607da25d7a3a47328c67889db509979a&elqaid=3124&elqat=1&ref=fdaweb.com) issued by the International Council for Harmonization. They are: 

- Good Clinical Practice: Integrated Addendum – amends a previous guidance, *Good Clinical Practice: Consolidated Guidance*, to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also updating standards for electronic records and essential documents.
- Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population – an addendum to a 2000 guidance intended to provide high-level guidance on the implementation of important approaches in pediatric drug development.
- Genomic Sampling and Management of Genomic Data – to provide harmonized principles of genomic sampling and of management of genomic data in clinical studies to foster interactions among stakeholders and to encourage genomic research within clinical studies.
- Assessment and Control of Deoxyribonucleic Act Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk – discussing acceptable intake limits derived for some chemicals that are considered to be mutagenic carcinogens and are also commonly used in the synthesis of pharmaceuticals.