Department of Health and Human Services, Food and Drug Administration: Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed
GAO-03-940R: Jun 25, 2003
- Full Report:
GAO reviewed the Department of Health and Human Services, Food and Drug Administration's (FDA) rule on applications for FDA approval to market a new drug. GAO found that (1) the final rule amends FDA's patent submission and listing requirements for new drug applications, and (2) FDA complied with the applicable requirements in promulgating the rule.