FDA Publishes New Guidance for Industry on Generic Drug Development and Application Submission During the COVID-19 Public Health Emergency
On April 5, 2021, FDA published a new guidance for industry, Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers. FDA has received questions 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. FDA has collected these questions and is providing the responses in this guidance document 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. FDA intends to revise and update this guidance as appropriate.
FDA 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. The ongoing development of generic drugs submitted as ANDAs to the FDA for assessment helps Americans continue to have access to safe, effective generic drugs.
Additional Resources
In January 2021, FDA issued a related guidance, Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency, to facilitate the safe conduct of bioequivalence studies during the COVID-19 public health emergency.
OGD encourages prospective applicants to submit controlled correspondence with any inquiries about generic drug development or ANDA submission preparation.
