Editing New Drug Application (section)

{{Short description|Request US FDA approve new medications}}
{{Use mdy dates|date=July 2012}}
{{Regulation of therapeutic goods in the United States}}
[[File:New Drug Application (FDA 148) (8210965141).jpg|thumb|right|A new drug application in the 1930s for [[sulfapyridine]] to the United States [[Food and Drug Administration]]]]

The [[Food and Drug Administration]]'s (FDA) '''New Drug Application''' ('''NDA''') is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.<ref name="fdaddp">{{cite web|title=The Drug Development Process|url=https://www.fda.gov/ForPatients/Approvals/Drugs/default.htm|archive-url=https://web.archive.org/web/20141018095920/http://www.fda.gov/ForPatients/Approvals/Drugs/default.htm|url-status=dead|archive-date=October 18, 2014|publisher=U.S. Food and Drug Administration|access-date=1 May 2018|date=4 January 2018}}</ref><ref name="fda2018-4">{{cite web|title=The Drug Development Process. Step 4: FDA Drug Review|url=https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405570.htm|archive-url=https://web.archive.org/web/20141023071455/http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405570.htm|url-status=dead|archive-date=October 23, 2014|publisher=U.S. Food and Drug Administration|access-date=1 May 2018|date=4 January 2018}}</ref> Some 30% or less of initial drug candidates proceed through the entire multi-year process of [[drug development]], concluding with an approved NDA, if successful.<ref name=fdaddp/>

The goals of the NDA are to provide enough information to permit FDA reviewers to establish the complete history of the candidate drug.<ref name="gad08">{{cite book |last1=Gad |first1=Shayne Cox |title=Pharmaceutical Manufacturing Handbook: Production and Processes |date=2008 |publisher=John Wiley & Sons |isbn=9780470259801 |url=https://books.google.com/books?id=4c0Hp3AOi8UC&pg=PA39}}</ref> Among facts needed for the application are:<ref name=fda2018-4/>
* [[Patent]] and manufacturing information
* Drug safety and specific effectiveness for its proposed use(s) when used as directed
* Reports on the design, compliance, and conclusions of completed [[clinical trial]]s by the [[Institutional Review Board]]
* Drug susceptibility to [[substance abuse|abuse]]
* Proposed labeling ([[package insert]]) and directions for use

Exceptions to this process include voter driven initiatives for [[Medical cannabis|medical marijuana]]<ref>{{cite web|url=https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421163.htm|title=Public Health Focus - FDA and Marijuana|first=Office of the|last=Commissioner|website=www.fda.gov|access-date=April 30, 2018|url-status=dead|archive-url=https://web.archive.org/web/20180428162411/https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421163.htm|archive-date=April 28, 2018|df=mdy-all}}</ref> in certain states.