EFTA01734942Set 10
2016-09-1615p5,915w
intended to serve as a focus for continued discussions among
24 the Division of Bone, Reproductive, and Urologic Products, pharmaceutical companies, the
25 academic community, and the public.3 ... medication or other drug substance
I This guidance has been prepared by the Division of Bone, Reproductive, and Urologic Products in the Center for
Drug Evaluation and Rcscarch
https://www.justice.gov/epstein/files/DataSet%2010/EFTA01734942.pdf