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The four biggest changes from the FDA rule to clarify Hatch-Waxman procedures

Natalie Rahhal, New York


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 important...


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