The four biggest changes from the FDA rule to clarify Hatch-Waxman procedures
The FDA’s “Abbreviated New Drug Applications and 505(b)(2) Applications” final rule was issued in October last year. It is long and mostly codifies standard practices, but Natalie Rahhal picks out a few changes that could have a bigger effect on Hatch-Waxman practitioners
Four months on from the introduction of a Food and Drug
Administration (FDA) final rule, "Abbreviated New Drug
Applications and 505(b)(2) Applications" the amendments
haven’t seemed to rock the regulatory space or
Hatch-Waxman litigation profoundly. However, there are some
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