FDA Revises Covid ANDA Q&A Guidance

FDA has revised a guidance, Development of Abbreviated New Drug Applications During the Covid-19 Pandemic—Questions and Answers, which collects questions the agency has received from prospective applicants and applicants of ANDAs about generic drug product development and application assessment during the Covid-19 public health emergency. The 4/2021 document 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 revisions 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.