NDA FDA Review Time

I am making project report on the topic New Drug Application (NDA) FDA and searching for details related to this. Will you provide me basic details related to NDA FDA Review Time so I can place report in my report also provide contact details and address so that I can visit there?

[Rajkumar Agarwal]

Though FDA reviewers are involved with a drug's development throughout the IND stage, the official review time is the length of time it takes to review a new drug application and issue an action letter

Drug Review Steps Simplified

Preclinical (animal) testing.
An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.
Phase 1 studies (typically involve 20 to 80 people).
Phase 2 studies (typically involve a few dozen to about 300 people).
Phase 3 studies (typically involve several hundred to about 3,000 people).
The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.
The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug).
The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
FDA reviewers will approve the application or issue a complete response letter.

Contact:

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
1-888-INFO-FDA (1-888-463-6332)