Approvable letters in the FDA new drug approval process.
Center for the Study of Drug Development, Tufts University, Boston, MA 02111.
B W
BW
Richard
M
M
Ulcickas
L
L
Lasagna
D006801:Humans; D007880:Legislation, Drug; D008004:Licensure; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration