Information About Adaptive Designs for Bioequivalence Studies in ANDA Submissions The U.S. Food and Drug Administration continues to seek approaches to mitigate the study challenges posed by the COVID-19 public health emergency, which has presented unprecedented challenges to conducting in-vivo bioequivalence (BE) studies for abbreviated new drug application (ANDA) applicants, including study interruptions. The Office of Generic Drugs (OGD) has received numerous controlled correspondences on this topic during the public health emergency and recognizes that interrupting and restarting BE studies for ANDAs may require protocol revisions and impact the collection of information needed to establish bioequivalence. In April 2020, FDA posted a Bioequivalence Studies for Submission in ANDAs during the COVID-19 Pandemic web page to provide information to current and prospective ANDA applicants about prioritizing the protection of study participants and to provide OGD contact information to applicants with questions. Today, FDA updated the web page with information about how applicants may submit specific questions related to proposed modifications to study protocols, including modifications to incorporate adaptive designs. The FDA guidance "Adaptive Designs for Clinical Trials of Drugs and Biologics" provides general scientific principles on adaptive designs but does not specifically address bioequivalence studies in support of ANDAs. A recently published article presents a survey summary of bioequivalence (BE) studies with adaptive designs in ANDAs, and discusses the challenges and potential opportunities for implementing adaptive designs for BE studies on generic drugs. (Please note that the opinions expressed in this article are those of the authors and should not be interpreted as the position of the U.S. Food and Drug Administration.) Due to the challenges posed by the COVID-19 public health emergency on participation in BE studies, an adaptive study design may be a useful protocol revision for ANDA applicants. For example, an adaptive design may allow for additional subjects to be included in response to a larger than usual dropout rate. OGD encourages current and prospective applicants to submit specific questions related to their impacted bioequivalence studies, including questions about protocol revisions and information collection, via the controlled correspondence process or other appropriate avenues. More information is available on FDA's website. | 
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