FDA recognizes that the COVID-19 pandemic may impact the conduct of bioequivalence studies intended for submission in Abbreviated New Drug Applications (ANDAs). For example, challenges may arise from quarantines, site closures, travel limitations, interruptions to the supply chain for the proposed generic product or the reference listed drug product, or other considerations if site personnel or study subjects become infected with COVID-19. In addition, the process of interrupting and restarting bioequivalence studies for ANDAs may require protocol revisions and impact the collection of information needed to establish bioequivalence.
Prioritize Protection of Participants
For bioequivalence studies intended for submission in ANDAs that have been impacted by COVID-19, ANDA applicants should prioritize the protection of the study participants as they consider restarting these studies. For general considerations regarding the conduct of in vivo bioequivalence studies during the COVID-19 public health emergency, please consult the most recent version of the FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Public Health Emergency, available at COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders.
For ANDAs that have already been submitted to FDA, ANDA applicants should direct questions to the Regulatory Project Manager for their ANDA.
- For ANDAs that have not yet been submitted to FDA, potential applicants should submit specific questions related to their impacted bioequivalence studies, including questions about protocol revisions and information collection, via the controlled correspondence process. As appropriate, please provide detailed information including your proposed plans, rationale, and justification supporting your proposal. For additional information on the controlled correspondence process, please consult the draft guidance Controlled Correspondence Related to Generic Drug Development (November 2017). OGD will prioritize responses to controlled correspondence for COVID-related questions.
- Potential applicants may submit general questions related to the impact of COVID-19 on bioequivalence studies to email@example.com.
- Potential applicants may also notify FDA via firstname.lastname@example.org of any bioequivalence studies that have been interrupted. Please include the name of the drug product, the study design and the point of interruption. This will help FDA identify the needs for additional information or guidance on these matters.
FDA may update this site, as appropriate, to provide additional information related to the impact of the COVID-19 pandemic on the conduct of bioequivalence studies intended for submission in ANDAs based on the inquiries that FDA receives.
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