Welcome to our informative slide on the New Drug Application (NDA) - a pivotal milestone in the pharmaceutical world that propels medical innovation to new heights. In this concise presentation, we'll explore the significance of the NDA process and its critical role in bringing life-changing medications to patients in need.

1. NDA- New Drug
Application
Dharmender Yadav
YouTube: PHARMA HOTSPOT

2. NEW DRUG APPLICATION
NDA stands for "New Drug Application"
It is an Application submitted by the sponsor to regulatory
authorities, such as the U.S. Food and Drug Administration
(FDA), seeking approval to market and sell a new
pharmaceutical drug.
The NDA includes data from preclinical and clinical studies, as
well as information on the drug's safety, efficacy, and
manufacturing processes.
Approval of an NDA is necessary before the drug can be
commercially available to the public.

3. The Drug Development Process
IND
Application
Filling
NDA
Filling
Animal testing of
a Drug
Pre Clinical
studies
Short Term
FDA Approval
Phase-IV
Post Marketing
Surveillance
Clinical studies
20-100 100-300 1000-3000
Individuals individuals individuals
Phase-I Phase-II Phase-III
1-2 Years 1-2 Years 2-3 Years
Long Term
Safety Efficacy Confirm
& Safety Safety & efficay
Drug
Discovery
&
Development

4. What are New Drugs
A drug that contains a new chemical entity as
its active ingredient would be considered as a
new drug.
A drug’s recommended new use or change in
recommended dosage, dosage form or route of
administration also can be considered to be a
new drug.

5. Goals of NDA
The goals of the New Drug Application (NDA) are to provide
enough information to permit FDA reviewers to establish the
following:
• Is the drug safe and effective in its proposed use and do the
benefits outweigh the risks ?
• Is the proposed labelling (package inset) is appropriate and
what should it contain ?
• Are the methods used in manufacturing – GMP (Good
Manufacturing practice) and the controls used to maintain
drug’s quality adequate to preserve its identity, strength,
quality and purity.

6. NDA FORMS
1. Form FDA-356h Application to Market a New Drug,
Biologic or an Antibiotic drug for Human use.
It includes:
• Applicant information
• Product/Manufacturing information
• Pre-clinical studies
• Clinical studies
• Labelling

7. NDA FORMS
2. Form FDA-3397 User fee cover sheet
• FDA has the authority to collect user fees for certain
drugs and biologics license applications.
• Pharmaceutical companies pay for the review of certain
new drugs, biologics or supplements.
• User fee cover provide necessary information that help
to determine whether a fee is applicable or not
• It also helps FDA to track payments.

8. NDA FORMS
3. Form FDA-3331 NDA Field Alert Report
• FAR (Field Alert Report) is submitted to the FDA
when the drug is already distributed in the market and
the manufacturer become aware of any information
that can affect the identity, quality, strength or potency
of the drug.
• This reporting mechanism is crucial for the FDA to take
appropriate actions in addressing potential safety
concerns, issuing drug recalls if necessary, and ensuring
patient safety.

9. NDA COPIES
FDA requires drug sponsors to submit multiple copies of the
NDA.
1. ARCHIVAL COPY:
• The cover letter
• The administrative section
• It must contain four copies of labelling section
• It must contain additional three copies of CMC and
methods validation package in a separate binder
• Only the folder that contains the case report
tabulation and case report forms

10. 2. REVIEW COPY:
• It contains NDA’s technical sections along with the
cover letter form FDA-356h,
• NDA index as well as individual table of content,
labelling sections, and application summary.
3. FIELD COPY:
• It is required by FDA inspectors during pre-approval
facilities inspections.
• In addition to content of review copy, this includes
CMC (Chemistry, Manufacturing and Controls) and
methods validation package.

11. NDA Contents
NDA contains 20 different sections in addition to the form FDA-356h itself.
Specific content of NDA will depend on:
• Nature of the drug
• Information available at the time of submission.

12. NDA Contents
o NDA Section 1: Index
o NDA Section 2: labelling
o NDA Section3: application summary
o NDA Section 4: Chemistry , Manufacturing, controls (CMC)
o NDA Section 5: Non-clinical pharmacology and Toxicology
o NDA Section 6: Human pharmacokinetics and Bioavailability
o NDA Section 7: Microbiology
o NDA Section 8: clinical data
o NDA Section 9: Safety Update Reports
o NDA Section 10: Statistics

13. NDA Contents
o NDA Section 11: Case Report Form Tabulations
o NDA Section 12: Case Report Forms
o NDA Section 13: Patent Information
o NDA Section 14: Patent Certification
o NDA Section 15: Establishment Description
o NDA Section 16: Debarment Certificate
o NDA Section 17: Field Copy Certification
o NDA Section 18: User Fee Coversheet
o NDA Section 19: Financial Disclosure
o NDA Section 20: others

14. FDA Drug Approval Process
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 formulation are,
 the results of the animal studies,
 how the drug behaves in the body, and
 how it is manufactured, processed and packaged.
• Once the Application is submitted, FDA has 60 days to conduct
preliminary review which assess whether the NDA is “sufficiently
complete to permit a substantive review”.
• If everything is acceptable FDA decide if the NDA will get standard or
accelerated review and communicate the acceptance and review
choice in another communication known as 74-day letter.
• A standard review may take 10 months for decision by FDA reviewers
while the decision is made within 6 months in accelerated review.

15. NDA REVIEW PROCESS

16. Thank You