USA – FDA issues 36 new and revised product-specific guidances

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).
 
The latest batch of guidances includes 22 new and 14 revised draft guidances covering drugs to treat prostate cancer, hepatitis C, multiple sclerosis and numerous other conditions.
 
With the new release, FDA says it has published 1,885 product-specific guidances. With the previous batch of product-specific guidances last November the agency had reported the total to be 1,974, which it says was due to an error that caused some of the guidances to be counted twice. (RELATED: FDA issues 34 new and revised product-specific guidancesRegulatory Focus 18 November 2020)…