In early September 2021, the United States Food and Drug Administration (FDA) revised its Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry document. The update builds on the previous guidance on ANDA applications submitted during the COVID-19 pandemic, published in April 2021.
ANDA Submission
In the revised document, the FDA clarifies when it will accept requests to receive an ANDA with “less than the full complement of recommended stability data” and how to handle expired batches of test product in interrupted bioequivalence studies. It also includes some minor updates to the Frequently Asked Questions.
FDA 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.” Additionally, products that meet its criteria for priority review to address the COVID-19 pandemic may also be accepted to receive an ANDA with less than the full complement of recommended stability data.
The guidance also notes that the FDA is continuing to prioritize the review of ANDA submissions that might help address COVID-19. As part of its evaluation of whether a submission could help address the current public health emergency, FDA will consider whether the ANDA is (1) for a drug being investigated to treat or prevent COVID-19, but is not labeled for this use, or (2) for a drug being used for its labeled use to treat or prevent secondary conditions associated with COVID-19.
Additional Flexibility for Test Product Batches
FDA will also give flexibility to generic drugmakers when it comes to resuming bioequivalence studies that were interrupted by the COVID-19 public health emergency. According to the revised guidance, prospective applicants can use a test product batch 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.”
If an applicant wants to take advantage of this flexibility, it will need to 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] study.”
The test batch may be considered acceptable if the submitted stability data meet the drug product shelf-life specifications. The acceptability of this approach will be determined during the ANDA review.
In the alternate, prospective applicants are generally permitted to manufacture additional test product to resupply its BE studies, subject to certain recommendations outlined in the guidance document. One such recommendation is that the new test product batch (with the same formulation) should be manufactured using the same equipment under the same manufacturing conditions as those for the previously manufactured test batches. Additionally, the batch size of the proposed new test product batch should be based on the batch size recommendations provided in the May 2014 guidance for industry, ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers.