August 2024 SOCRA Source Journal - Journal - Page 42
study drug is returned to the
sponsor or destroyed.
Submission of a New Drug
Application to FDA
After study close-out, the clinical
trial data are analyzed. If the
data are favorable, the sponsor
submits a New Drug Application
(NDA) to the FDA for review.
FDA approval certi昀椀es that the
drug is adequately safe and
effective for marketing. Table 7
highlights the contents of the
NDA, which enables the FDA
to perform a comprehensive
review of the submission.
The Commercial and
Production Processes
The work does not stop at the
昀椀rst approval. It moves into
commercial production and realworld evaluation. Many steps
are involved in manufacturing
the drug and then preparing
to launch the drug in the
marketplace. Once the drug
has been manufactured, it is
prescription-ready and can
42
TABLE 7
New Drug Application Overview
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Index
Labeling
Summary
Chemistry section (CMC, samples, and methods validation)
Nonclinical pharmacology and toxicology
Human PK and bioavailability
Clinical microbiology
Clinical data
Safety update report
Statistical section
Case report tabulations
Case report forms
Patent information
User fee cover sheet
Financial information
move from provider to patient and payer.
Conclusion
While multiple steps and organizations are involved in the process
leading to an approved therapeutic treatment, this article provided a
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