NEWS/EVENTS
March 2010 Contract Pharma
Trends in 505(b)(2)Approvals
By Loren Gelber, chief scientific officer at RRI Group, Inc.
The 505(b)(2) NDA is a type of new drug application that was created by the amendments to the Food, Drug and Cosmetic Act of 1984, commonly referred to as Waxman-Hatch (or Hatch-Waxman when Republicans have the upper hand)1. This type of application is intermediate between the full NDA required for a new drug that is a new chemical entity never before approved in the U.S. and an ANDA used to get generic drugs approved. Some of the information needed for approval of a 505(b)(2) NDA is not owned by the applicant, but may be either a reference to information in the application of a reference-listed drug, or taken from the published scientific literature2…more
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