02 Dec
02Dec

Today, the Food and Drug Administration issued a draft guidance for industry, “Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications.” The guidance assists sponsors of investigational new drug applications and new drug applications during drug development in evaluating the need for and design of drug-drug interaction (DDI) studies involving acid-reducing agents (ARAs).  

Today, the Food and Drug Administration issued a draft guidance for industry, “Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications.” The guidance assists sponsors of investigational new drug applications and new drug applications during drug development in evaluating the need for and design of drug-drug interaction (DDI) studies involving acid-reducing agents (ARAs).  

The draft guidance discusses when drug developers should conduct DDI studies with ARAs and provides recommendations on the design and conduct of DDI studies. The guidance also discusses interpreting and communicating the results and recommendations from these studies. 

FDA is publishing this draft guidance to collect additional public comments. You may submit comments on the draft guidance to the docket (Docket No. FDA-2020-D-1794) available at https://www.regulations.gov. This draft guidance, when finalized, will represent the FDA’s current thinking on this topic.

Source: USFDA

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