FDA Adds New Product-Specific Guidances, Reopens Comment Period

The FDA has reopened the comment period for 29 new product-specific draft guidances and 22 revised draft guidances for complex and non-complex generic drug products, with a new deadline for comments of April 18.

The agency has also issued 15 new draft product-specific guidances, which include sirolimus and sotorasib, and six revised draft product-specific guidances for drug products such as hydroxyurea and mirabegron.

The deadline for comments of these new and revised draft product-specific guidances is also April 18.

View the updated guidance list here: https://bit.ly/3kakWHA.