FDA revises guidance for generics applications during pandemic

On September 8, the US Food and Drug Administration revised the guidance for industry  Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers, originally published in April 2021.

The guidance collects questions the FDA has received from prospective applicants and applicants of abbreviated new drug applications (ANDAs) about generic drug product development and application assessment during the COVID-19 public health emergency and provides formal responses for the benefit of all stakeholders.

The guidance provides general recommendations in the form of questions and answers in topic categories including generic drug product development, ANDA submission and assessment, and marketing and exclusivity. The FDA updates this guidance as appropriate, and this revision includes: