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Home » FDA Adds New Product-Specific Guidances, Reopens Comment Period
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.
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