An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products

Manning, ML; Thompson, MD; Saber, H; Maher, VE; Crich, JZ; Leighton, JK

Saber, H (corresponding author), US FDA, Off Hematol & Oncol Prod, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20903 USA.

REGULATORY TOXICOLOGY AND PHARMACOLOGY, 2020; 110 ():

Abstract

A systematic analysis of new commercial investigational new drug applications (IND) submitted to the FDA's Office of Hematology and Oncology Products ......

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