Editing New Drug Application (section)

==Before trials==
To legally test the drug on human subjects in the United States, the maker must first obtain an [[Investigational New Drug]] (IND) designation from FDA.<ref name="fda2018-3">{{cite web|title=The Drug Development Process. Step 3: Clinical Research|url=https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm|publisher=U.S. Food and Drug Administration|access-date=1 May 2018|date=4 January 2018}}{{dead link|date=May 2025|bot=medic}}{{cbignore|bot=medic}}</ref>  This application is based on nonclinical data, typically from a combination of in vivo and in vitro laboratory safety studies, that shows the drug is safe enough to test in humans.<ref name=fda2018-3/> Often the "new" drugs that are submitted for approval include [[New chemical entity|new molecular entities]]<ref name="fda2018-1">{{cite web|title=The Drug Development Process. Step 1: Discovery and Development|url=https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405382.htm|archive-url=https://web.archive.org/web/20150310091023/http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405382.htm|url-status=dead|archive-date=March 10, 2015|publisher=U.S. Food and Drug Administration|access-date=1 May 2018|date=4 January 2018}}</ref> or old medications that have been chemically modified to elicit differential pharmacological effects or reduced [[side effect]]s.