FDA issues 36 new and revised product-specific guidances

FDA issues 36 new and revised product-specific guidances

Source: 
RAPS.org
snippet: 

The US Food and Drug Administration (FDA) this week issued 36 new and revised draft product-specific guidances meant to facilitate the development of generic drugs by clarifying the agency’s expectations for the studies required to demonstrate bioequivalence (BE) to a reference listed drug (RLD).