Former FDA official criticizes agency's guidance on drug reviews during COVID-19 pandemic

The US Food and Drug Administration’s recent guidance on new drug applications during the pandemic fails to address certain key issues, according to a former top FDA official.

The guidance provides applicants with recommendations for navigating the product review process in a Q&A format. Topics covered include generic drug product development, submission and assessment of abbreviated new drug applications (ANDAs), and marketing and exclusivity.

However, according to Eva Temkin, former FDA Acting Director for Policy at the Office of Therapeutic Biologics and Biosimilars, the guidance is silent on important topics that have arisen over the last year and which will continue to be relevant in 2021.