Article | June 2, 2020

COVID-19 Treatment Development: Updates And Recent FDA Guidance

Source: Rho

By Theresa Scocca and Monica Frazier

Changes In Regulatory Requirements For Biosimilar Development In India

The FDA continues to release additional information and update their website as the COVID-19 pandemic continues and both regulatory professionals and drug developers react to the potential for novel and repurposed products to treat COVID-19. Recent changes to the Coronavirus Treatment Acceleration Program (CTAP) webpage have included additional details about how to proceed based on whether the product of interest will be reviewed by CDER or CBER (or if jurisdiction is undetermined). In addition, two new guidance documents for COVID-19 treatment development have been released in May 2020. Continue reading to learn more about these updates.

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