Editing New Drug Application (section)

==The actual application==
The results of the testing program are codified in an FDA-approved public document that is called the ''product label,'' package insert or Full Prescribing Information.<ref>21 CFR 201.5: Labeling Requirements for Prescription Drugs and/or Insulin</ref> The prescribing information is widely available on the web from the FDA,<ref name="DailyMed">{{Cite web|url=http://dailymed.nlm.nih.gov/dailymed/about.cfm|title=Daily Med:Current Medication Information|access-date=October 10, 2007|url-status=live|archive-url=https://web.archive.org/web/20081112024512/http://dailymed.nlm.nih.gov/dailymed/about.cfm|archive-date=November 12, 2008|df=mdy-all}}</ref> drug manufacturers, and frequently inserted into drug packages. The main purpose of a drug label is to provide healthcare providers and consumers with adequate information and directions for the safe use of the drug.

The documentation required in an NDA is supposed to tell "the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.”<ref name=fda2018-4/> Once approval of an NDA is obtained, the new drug can be legally marketed starting that day in the United States.

Once the application is submitted, the FDA has 60 days to conduct a preliminary review, which assesses whether the NDA is "sufficiently complete to permit a substantive review." If the FDA finds the NDA insufficiently complete, then the FDA rejects the application by sending the applicant a ''Refuse to File'' letter, which explains where the application failed to meet requirements.<ref>{{cite web|url=http://www.medicalnewstoday.com/articles/172522.php|title=Merck KGaA Receives Refuse To File Letter From FDA On Cladribine Tablets New Drug Application|website=medicalnewstoday.com|access-date=April 30, 2018|archive-url=https://web.archive.org/web/20100305060217/http://www.medicalnewstoday.com/articles/172522.php|archive-date=March 5, 2010|df=mdy-all}}</ref> Where the application cannot be granted for substantive reasons, the FDA issues a [[Complete Response Letter]].

Assuming the FDA finds the NDA acceptable, a ''74-day letter'' is published.<ref name=findings>{{cite web |publisher=Food and Drug Administration |url=https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm127153.htm |title=FINDINGS: Issues and Communication: Independent Evaluation of FDA's First Cycle Review Performance – Final Report |access-date=2010-02-23 |url-status=dead |archive-url=https://web.archive.org/web/20100308034550/https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm127153.htm |archive-date=March 8, 2010 |df=mdy-all }}</ref> A ''standard review'' implies an FDA decision within about 10 months while a ''[[priority review]]'' should complete within 6 months.<ref>{{cite web|url=https://www.drugs.com/nda/acetavance_090715.html|title=Cadence Pharmaceuticals Announces Priority Review and Acceptance of NDA Submission for Acetavance for Treatment of Acute Pain and Fever|website=drugs.com|access-date=April 30, 2018|url-status=live|archive-url=https://web.archive.org/web/20170711032241/https://www.drugs.com/nda/acetavance_090715.html|archive-date=July 11, 2017|df=mdy-all}}</ref>