At the end of December, FDA released additional new (28) and revised (15) draft guidances providing product-specific recommendations on the design of bioequivalence (BE) studies to support ANDA submissions. The guidances were developed in accord with the process described in the agency’s 2010 guidance on “Bioequivalence Recommendations for Specific Products.” Comments on the new drafts are due by March 2.
[/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″]
