Development of Biosimilar and Interchangeable Biological Products During the COVID-19 Pandemic: What the ANDA Guidance Left Unsaid
By EsqSocial Corporation 23/04/21
There has been much discussion about FDA’s recently-issued guidance regarding the development and review of abbreviated new drug applications (“ANDAs”) during the COVID-19 pandemic. The guidance, “Development of Abbreviated New Drug Applications During the COVID-19 Pandemic—Questions and Answers” (“COVID Q&A Guidance”), also leaves much unsaid. Notably, the guidance stops short of extending the Agency’s thinking on the articulated scientific and regulatory principles from small molecule generics...
By: King & Spalding