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Regulations & EHS&S



FDA issues new guidances to promote harmonization of regulatory requirements


12/04/2018
The Food and Drug Administration is announcing the availability of the following final guidances:
 
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.