New drug application (NDA) NDA content

 

New drug application (NDA)

Critical component for drug approval process which required to submit to USFDA before drug commercialization.

The data gathered during the animal studies and human clinical trials of IND become part of the NDA.

Goal

The NDA provide enough information to permit FDA reviewer to reach safety, efficacy and quality for pharmaceutical production.

NDA content

1.   Index

2.   Labeling

3.   Summary

4.   Chemistry section

5.   Nonclinical pharmacology and toxicology section

6.   Human pharmacokinetics and bioavailability section

7.   Clinical microbiology section

8.   Clinical data section

9.   Safety update report

10.   Statistical section

11.    Case report tabulations

12.  Case report forms

13.  Patent information on any patent

14.   Patent certification

15.    Establishment description

16.    Debarment certification

17.   Field copy certification

18.   User fee cover sheet

19. Financial information

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