Federal Register
Notice: FDA is holding a public workshop 1/9/07 on issues related to the application process for seeking approval for marketed unapproved drugs. The workshop will be held from 9 a.m. to 4 p.m. at CDER’s Conference Room, 5630 Fishers Lane, Rm. 1066, Rockville, MD. Its purpose is to provide clarification and direction to businesses on how to seek approval to legally market drugs through the NDA and ANDA processes and how to legally market drugs through compliance with the over-the-counter monographs. Contact Karen Kirchberg, (301) 827-8916. To view this notice, click here.