USA – FDA Releases 81 Product-Specific Guidances

The US Food and Drug Administration (FDA) on Thursday released product-specific guidance documents for 81 active pharmaceutical ingredients to aid generic drug development, including 28 new draft guidances and 53 revised draft guidances.

The guidances, when finalized, are intended to promote generic competition by clarifying FDA’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug. So far, FDA has issued nearly 1,800 product-specific guidances…