The document discusses the New Drug Application (NDA) process in the United States. It provides an overview of the history and goal of the NDA, the application format and forms, contents of an NDA, and the FDA approval process. The NDA is submitted to the FDA by drug companies to obtain approval to market a new pharmaceutical product. It contains extensive information on the drug's safety, efficacy, manufacturing and quality controls. The FDA review process involves evaluation of the application by medical and regulatory experts to determine if the drug's benefits outweigh its risks.

1. Presented By:-
Mr. Sachin R. Naksakhare
M.Pharm Sem-II
Guided By:-
Dr. R. P. Bhole
Dr. D .Y Patil Institute Of Pharmaceutical Science and
Research, Pimpri, Pune
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2. • INTRODUCTION
• HISTORY
• GOAL OF NDA
• FORMAT OF APPLICATION
• APPLICATION FORM
• FORM’S USED IN NDA
• NDA CONTENTS
• FDA- APPROVAL PROCESS
• REVIEW PROCESS
• COMMON TECHNICAL DOCUMENTS
• REFERENCE
Contents

3. Introduction
The NDA application is the vehicle through which drug
sponsors, such as biotech and pharmaceutical companies,
formally propose that the FDA approve a new
pharmaceutical for sale and marketing.
For decades, the regulation and control of new drugs in the
United States has been based on the New Drug Application
(NDA).
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4. HISTORY
 When the Federal Food, drug and cosmetic act of 1938 was
passed, a new area of drug product development began.
The act required the assurance of safety and stated minimum
requirements for manufacturing and quality control.
It provided only 60 days for review by FDA before the distribution
of any new drug product.
The 1962 kefauver-Harris Amendments to the act required
greatly increased information concerning the safety ,
effectiveness, quality, sale , use , manufacturing and controls of
the drug products.
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5. Definitions
Drug
Drug are the substance intended to be used for or in the diagnosis,
treatment, mitigation, or prevention of any disease or disorder in
human being or animal.
New Drug
A new substance of chemical, biological, or biotechnological origin in
bulk or prepared dosage form used for Diagnosis, Treatment,
Mitigation or Prevention of any disease or disorder in Human or
Animal which except during local clinical trial has not been used in
the country to any significant extent and during local clinical trials has
not been recognized in the country as effective and safe for the
proposed claims.
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6.  An application submitted by the manufacturer of a drug to the
FDA - after clinical trials have been completed - for a license to
market the drug for a specified.
 New Drug Application (NDA) is the vehicle in the United States
through which drug sponsors formally propose that the FDA
approve a new.
New Drug Application (NDA)
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7. GOAL OF NDA
Provide enough information to permit FDA reviewers to
establish the following:
 Safety & effectiveness of drug?
 Benefits overweigh risks?
 Is the drug’s proposed labelling (Package insert)
appropriate, and what should it contain?
 Are the methods used in manufacturing (GMP) the drug
and the controls used to maintain the drug’s quality
adequate to preserve the drug’s identity, strength, quality,
and purity? 7
Risk Benefit

8. FORMAT OF APPLICATION
8
FDA
Review
Archival
copy
Review
copy
Field
copy

9. 9
3 copies of the application are required:
 Archival copy
 Review copy
 Field copy
1. Archival copy:
This is a complete copy of an application submission and is
intended to serve as a reference source for FDA reviewers.
This contains information which not contained in the review copy .

10. 2. Review copy
It contains the NDA’s technical section along with cover
letter, form FDA-356h ,NDA index as well as individual
content , labeling section and application summary.
3. Field copy
This is required by the FDA inspectors during pre-
approval facilities inspections.
It is implemented in 1993.
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11. APPLICATION FORM
The applicant shall submit a completed & signed application form
that contains:
 The name address of the applicant,
 The date of the application,
 The application number if previously issued,
 The name of the product, including its established, code &
chemical names,
 The dosage form & strength,
 The route of administration,
 The identification numbers of all INDAS that are referenced in
the application,
 The identification numbers of all drug master files & other
applications under this part that are referenced in the application,
 The drug products proposed indications for use.
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12. FORM’S USED IN NDA
 Form FDA-356h. Application to market a new drug, biological or an
antibiotic drug for human use.
 Form FDA 3397. User fee cover sheet.
 Form FDA 3331. New drug application field report.
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13. 13

14. 14

15. NDA Contents
The NDA have as many as 15 different section in addition to the
Form FDA 356h itself.
The specific content of NDA will depend on the nature of the
drug product and the information available at the time of
submission the application.
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16. NDA CONTENT
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section 1
Section 2
Section 3
Section 4
Chemistry , manufacturing and
control (CMC)
Section 5 Nonclinical pharmacology and toxicology
Index
summary
labeling

17. NDA Contents
17
Section 6
Section 7
Section 8
Section 9
Section 10
Human pharmacokinetics and bioavailability
Clinical microbiology
Clinical data
Safety update report
statistics

18. NDA CONTENTS
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Section 11
Section 13
Section 12
Section 14
Case report tabulation
Case report form
Patent information
Patent certification
Section 15 Other Which are remaining

19. FDA –Approval process
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20. 1. Fast track approval
Drug for
Serious disease.
Must be requested by the drug company .
FDA 60 days review decision.
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21. 2. Accelerated approval
In 1992 FDA instituted the accelerated approval regulation.
Based on surrogate endpoint, not on clinical outcome.
A surrogate endpoint is a marker- a laboratory measurement, or
physical sign that is used in clinical trial as an indirect or
substitute measurement that represent a clinically meaningful
outcome, such as survival or symptom improvement.
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22. 3. Priority review
 A priority review designation is given to drug that offer major
advances in treatment.
 The goal for completing a priority review is 6 month.
 It can given for drug used in serious/non serious disease.
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23. NDA Review Process
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24. At the end of that, the FDA is required to respond with an action letter.
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 An Approval letter
 An Approvable letter
 An Non Approvable letter
Three action letters

25. 1. Approval letter
It signifies that all substantive requirements for approval are met with
and that the sponsor company can begin marketing the drug as of the date
on letter.
2. Approvable letter
It signifies that application substantially complies with requirements but
has minor deficiencies that must be addressed before an approval letter is
sent.
Within 10 days of receipt sponsor must respond.
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26. 3. Non approvable letter
 It signifies that FDA has a major concern with the
application and will not approve the proposed drug
product for marketing as submitted.
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27. Example of NDAApproved products in 2017
Drug
Name and
Applicatio
n Number
Active
Ingredien
t
Dosage
Form/
Route
Submissi
on
Company Submissi
on
Classifica
tion
Submi
ssion
Status
1. Zofran
NDA#0200
07
Ondansetr
on HCL
Inj. SUPPL-47 Novartis
pharms.
Corp.
Labeling Appro
ved
2. Epanova
NDA#2050
60
Omega-3-
Carboxylic
Acids
Capsule;
Oral
SUPPL-3 Astrazene
ca Pharms
Labeling Appro
ved
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28. 28
Zofran Inj.
Epanova Capsule

29. Common Technical Documents
The ICH has developed a CTD to regulatory submission in three regions
of the globe i.e. Europe, US and Japan.
It includes data related to clinical, non –clinical and manufacturing of the
drug.
MODULE-1: Administrative Information
MODULE- 2: Quality Overall Summary
MODULE-3: Quality
MODULE-4: Non- Clinical Studies
MODULE-5: Clinical Studies
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30. MODULE 1
MODULE 3 MODULE 4 MODULE 5
Regional
Admin.
Information
Quality
Overall
summa
ry
Non
Clinical
overviewNon Clinical
Summary
Clinica
l
Overvi
ew
Clinical
Summary
Quality
Non
Clinical
Report
Clinical
Report
The CTD Triangle
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31. REFERENCE
 Vyawahare N. S. , Itkar S. C. “Drug Regulatory Affairs” Nirali
prakashan page no:-5.1-5.10
https://en.wikipedia.org/wiki/New drug application
https://www.fda.gov/drugs/developmentapprovalprocess
CFR Title 21 Part 312. Investigational New Drug Application.
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http://www.fda.gov/Drugs/Guidance Regulatory
Info:Accessed March 16, 2017.
http://www.fda.gov/downloads/AboutFDA/CentersOffices/Or
ganizationCharts/UCM144011.pdf. Accessed March 16, 2017.
http://CFR Title 21 Part 312. New Drug Application,
Accessed March 16, 2017.

32. REFERENCE
 Center for Biologics Evaluation and Research Organization.
March 16,2017. Available at:
http://www.fda.gov/AboutFDA/CentersOffices/
OrganizationCharts/ucm135943.htm. Accessed March 16, 2017
 Department of Health and Human Services Food and Drug
Administration Center for Drug Evaluation and Research.
Available at:
http://www.fda.gov/downloads/AboutFDA/CentersOffices/
OrganizationCharts/UCM144011.pdf. Accessed March 16, 2017
 Information for Sponsor-Investigators Submitting
Investigational New
Drug Applications (NDAs). March 16, 2017 Available at:
 http:// www.fda.gov/Drugs/DevelopmentApprovalProcess/
SmallBusinessAssistance/ucm071098.htm. Accessed March 16,
2017
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