FDA announced a new set of product-specific guidances to support industry in identifying appropriate science-based methodologies and evidence for developing generic drugs. The batch contains 74 product-specific guidances, including 22 new guidances and 52 revised guidances. Of these, 49 are for complex drugs, 16 of which have no approved generics. The agency has issued more than 1,682 product-specific guidances since 2007.
[/membership][membership level=”0,4″][The content continues for paid members only.]
Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership]
