Mark Schiffman, M.D., M.P.H. Senior Investigator, National Cancer Institute Executive Plaza South, Room 5026 6120 Executive Boulevard Bethesda, Maryland 20892-7335 301-435-3983 301-402-0916 schiffmm@mail.nih.gov Dear Dr. Schiffman: Since you are the first scientific officer to promote mass HPV vaccination of women as a means to prevent cervical cancer [1], and have been working with the […]
Accelerated Approval of Oncology Products: The Food and Drug Administration ExperienceAccelerated Approval of Oncology Products: The Food and Drug Administration Experience
John R. Johnson, Yang-Min Ning, Ann Farrell, Robert Justice, Patricia Keegan and Richard Pazdur Abstract We reviewed the regulatory history of the accelerated approval process and the US Food and Drug Administration (FDA) experience with accelerated approval of oncology products from its initiation in December 11, 1992, to July 1, 2010. The accelerated approval regulations […]
