Source : 'Generics Bulletin'
A US Food and Drug Administration question-and-answer document on the development of abbreviated new drug applications during the COVID-19 pandemic has today been updated by the agency to offer additional clarity and detail.
The latest version of the guidance replaces the initial iteration that was issued in April. ("FDA Guides On Generic Development During COVID-19" "Generics Bulletin" )
The document is intended to provide general recommendations to prospective and actual ANDA applicants on generic drug development and regulatory submissions, based on questions received and addressed by FDA during the COVID-19 pandemic, with a goal of providing “formal responses for the benefit of all stakeholders.”
Three categories of query are covered by the Q&A document, covering generic drug product development; submission, receipt and assessment of ANDAs; and marketing and exclusivity.
In April, the agency acknowledged that the guidance had initially been developed “without prior public comment, because FDA has determined that prior public participation for this guidance is not feasible or appropriate.” However, the agency said that it would continue to revise and update the guidance “as appropriate” to address new questions.
According to the FDA, revisions made to the latest version include:
Clarification on when FDA will accept requests to receive an ANDA with less than the full complement of recommended stability data;
Additional information on approaches for when a test product batch used in an interrupted bioequivalence study expires; and
Other minor updates to the frequently asked questions.
On the first point, the revised guidance states that “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, “during the COVID-19 public health emergency, FDA will generally accept such requests if the drug product meets the criteria for priority review to help address the COVID-19 public health emergency,” the agency added.
And on the second point, the guidance states that “in general, use of a batch of expired reference product to complete bioequivalence studies is not acceptable.” Addressing the question of whether a prospective ANDA applicant can use another unexpired batch of the reference product to complete the remaining studies, the document says that “it may be acceptable to utilize a different batch of unexpired reference product to complete a bioequivalence study, so long as the prospective applicant provides adequate scientific justifications for the use of different batches of reference product.”
Summarizing the need for the guidance, the FDA said it “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.”
As well as following the revised guidance on developing ANDAs and a separate guidance document on protecting participants in bioequivalence studies for ANDAs – issued in January ("FDA Guides On Bioequivalence Studies And COVID-19" "Generics Bulletin" ) – the agency’s Office of Generic Drugs urged prospective applicants to submit controlled correspondence with any enquiries about generic drug development or ANDA submission preparation.
By David Wallace