InternationalUSRemember you can easily switch between MIP US and MIP International at any time

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...

Please log in to read the rest of this article.

New to Managing Intellectual Property? Take advantage of free access to up to 5 articles on Managing IP and become a member today. It’s free to join and the benefits start straight away.

Already registered?

Please make sure you log in to read the rest of the article.

Log in

Join us now

Gain FREE access to up to five free articles when you register now.

Join here

Most read articles

Latest Country Updates