2004 update--180-day exclusivity under the Hatch-Waxman amendments to the federal Food, Drug, and Cosmetic Act.
This article updates the author's previously published article on the topic, provides some insight into recent events in this area of the law, and specifies a few minor items that were noted incorrectly in the earlier work.
Lietzan
Erika King
EK
Pharmaceutical Research and Manufacturers of America (PhRMA), Washington, D.C., USA.
D015507:Drugs, Investigational; D006801:Humans; D017387:Investigational New Drug Application / Q000331:legislation & jurisprudence; D007880:Legislation, Drug; D008389:Marketing of Health Services / Q000331:legislation & jurisprudence*; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration
D015507:Drugs, Investigational