Among the 54 product-specific guidances issued by FDA in September, 42 are new and 12 are revised. Twelve of the new drafts and 6 of the revised guidances are for complex drug products, 14 of which do not have generic competition. FDA published a statement describing the guidances as “FDA’s current thinking and expectations on how to develop generic drugs that are therapeutically equivalent to their respective reference-listed drugs.” Details on submitting comments on the draft guidances are available in the Federal Register.
[/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]
