FDA updates guidance on generic drug development during COVID

The US Food and Drug Administration (FDA) on Wednesday revised its questions and answers guidance on generic drug development and abbreviated new drug application (ANDA) submissions during the COVID-19 public health emergency.
 
The revised guidance updates the agency's previous guidance on generic drug development during the COVID-19 pandemic that was released in April 2021. (RELATED: FDA offers guidance on generic drug development during COVID, Regulatory Focus 5 April 2021)
 
The revisions include a clarification about when FDA will accept requests to receive an ANDA with "less than the full complement of recommended stability data," and information on how to handle expired batches of test product in interrupted bioequivalence studies. FDA also says it has made some minor updates throughout the frequently asked questions section.
 
"FDA recognizes that the COVID-19 public health emergency may impact the development of generic drug products, interrupt or delay ANDA applicants' bioequivalence studies, and impact the submission of ANDAs to FDA for assessment. The ongoing development of generic drugs submitted as ANDAs to the FDA for assessment helps Americans continue to have access to safe, effective generic drugs," FDA says.
 
In the revised guidance, FDA now explains that it will "generally accept requests to receive an ANDA with less than the full complement of recommended stability data if the drug product is on FDA's Drug Shortage List or FDA confirms that the drug product is vulnerable to shortage." The agency also says it will also generally do so for products that meet its criteria for priority review to help address the COVID-19 pandemic.
 
FDA is also granting generic drugmakers additional flexibility when it comes to resuming bioequivalence studies that were interrupted due to the COVID-19 public health emergency. The revised guidance now provides recommendations allowing prospective applicants to potentially use a test product batch that is beyond the established expiration dating period to resupply bioequivalence studies, "as long as sufficient evidence can be provided to demonstrate the acceptability of the test product batch."
 
FDA further explains that applicants who wish to follow this approach "should submit data to ensure the test batch samples stored at the long-term stability conditions beyond the current expiration date are in compliance with the finished drug product shelf-life specifications at the time of conducting the [bioequivalence] BE study."
 
FDA