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  1. How do patents relate to exclusivity?
    1. In general, FDA exclusivity is an effort to foster developments in the same way that patents do but FDA does not have any authority over patents. Patents are handled by the U.S. Patent and Trademark Office. When FDA says a company has X years of exclusivity, it means that FDA will not approve a generic version of the drug during that time period. When FDA lists a patent in the Orange Book, FDA means that it will not approve a generic version during the time that the patent is in effect.
  2. How do you find patent extensions in the Orange Book?
    1. You can't. You have to use the U.S. Patent and Trademark Office Web site. FDA and the Orange Book are de-linked from patents. FDA has no responsibility for patents. The company tells FDA its patent information and that information is then included in the Orange Book.
  3. When reviewing pediatric drug studies, does FDA consider possible effects of colors or flavors that are considered safe in adults, or is the focus merely on the active drug moiety?
    1. Yes, FDA definitely considers such excipients. FDA has a clinical toxicology review team and their role is to make sure that inactive ingredients are safe in children.
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