On 8th September 2021, FDA issued this guidance to provide general recommendations to prospective applicants and applicants of abbreviated new drug applications (ANDAs) related to generic drug product development and regulatory submissions in the form of questions and answers that have been received and addressed by the FDA during the COVID-19 public health emergency.
FDA has received questions from prospective applicants and applicants of ANDAs about generic drug product development and application assessment during the COVID-19 public health emergency.
The revised guidance comprises information for ANDA applicants on when the FDA will receive an ANDA with less than the full complement of recommended stability data and on approaches for when a test product batch used in the conduct of a bioequivalence study expires while the study is interrupted.
Also explains that the FDA will generally accept requests to receive an ANDA without all the recommended stability data if the drug product is on the FDA’s Drug Shortage List or the FDA confirms that the drug product is vulnerable to shortage
FDA intends to revise and update this guidance as appropriate to address new questions.