FDA updates generics guidance due to COVID-19 pandemic

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On 8 September 2021, the US Food and Drug Administration (FDA) revised its questions and answers guidance on generic drug development and abbreviated new drug application (ANDA) submissions during the COVID-19 public health emergency.

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The guidance collected questions FDA received from prospective applicants and applicants of ANDAs about generic drug product development and application assessment during pandemic. It aims to provide formal responses for the benefit of all stakeholders.

In the revised guidance updates, FDA stated that it recognizes that the COVID-19 pandemic has impacted the development of some generic drug products, and has interrupted or delayed ANDA applicants' bioequivalence studies, and the submission of ANDAs to FDA. As such, the updates have been issued to support the ongoing development of generic drugs to ensure that, ‘Americans continue to have access to safe, effective generic drugs’.

This is a further update to that issued in April 2021 [1] and includes:

  • Clarification on when FDA will accept requests to receive an ANDA with less than the full complement of recommended stability data
  • Additional information relevant to handling expired batches of test product in interrupted bioequivalence studies

In the revised guidance and considering the ongoing pandemic, FDA has outlined that it, if a drug product is on FDA's Drug Shortage List or if confirmed to be a product is vulnerable to shortage, it is likely to accept a request to receive an ANDA with less than the full complement of recommended stability data. This will also apply to products that meet its criteria for priority review.

There will also be a degree of additional flexibility for generics drugmakers when it comes to resuming bioequivalence studies that were interrupted due to the COVID-19 pandemic. For example, evidence is provided to show acceptability, prospective applicants may be able to use test product batches that are beyond the established expiration dating period to resupply bioequivalence studies. In such circumstances, data should be submitted to ensure and confirm compliance with the finished drug product shelf-life specifications at the time of conducting the bioequivalence study.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA guidance on generic drug development during COVID-19 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 1]. Available from: www.gabionline.net/guidelines/FDA-guidance-on-generic-drug-development-during-COVID-19

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