This document discusses new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submitted to the FDA for drug approval. It describes the goals and contents of an NDA, including clinical trial data and manufacturing information, as well as the multi-step review process. For ANDAs, the goals are to reduce drug costs and development time by allowing generics if they are equivalent to branded drugs. ANDAs must demonstrate bioequivalence but do not require new clinical trials. The document provides details on patent certification and approval processes for both NDA and ANDA submissions.

1. PRESENTED BY
Sneh Priya
Roll no-080603011
M Pharm part-1
Dept of Pharmaceutics
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2. Contents:
1.New Drug Application
a) Introduction.
b) Goal of NDA
c) Classification of NDA
d) New drug development review
e) NDA content
f ) NDA review process flow chart
g) The NDA in CTD Format
2. Abbreviated new drug application
a) Introduction
b) Goal of ANDA
c) ANDA contents
d) ANDA review process flow chart
e)Patent certification condition
3. Conclusion.
4. References. 2

3. New Drug Application
 Introduction
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 an Investigational New Drug
(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
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4. NDA Classifications
 New Molecular Entity
 New Salt of Previously Approved Drug (not a new molecular entity)
 New Formulation of Previously Approved Drug (not a new salt OR a
new molecular entity)
 New Combination of Two or More Drugs
 Already Marketed Drug Product - Duplication (i.e., new
manufacturer)
 New Indication (claim) for Already Marketed Drug (includes switch
in marketing status from prescription to OTC)
 Already Marketed Drug Product - No Previously Approved NDA
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5. New Drug Development and Review Process
Steps from Test Tube to New Drug Application Review
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6. Phases of clinical testing
Phase Number of
patients
Length Purpose Percent
successfully
completing
Phase1 20-100 Several months Mainly safety
67
Phase2 Up to several
hundred
Several months
to two years
Some short-term
safety but mainly
effectiveness
45
Phase3 Several hundred
to several
thousand
1-4 years Safety,
effectiveness,
dosage
5-10
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7. 7

8. 8

9. NDA Review Process
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10. NDA CONTENTS
 Section 1: Overall NDA index:-
The NDA index is a comprehensive table of contents that
enables the reviewers to find specific information in this
massive document quickly.
 Section 2: Labeling
It must include all draft labeling that is intended for use on
the product container, cartons or packages, including the
proposed package insert.
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11. CONTD....
Section 3: Application summary
 Proposed annotated package insert
 Pharmacology class, scientific rational, intended use, and
potential clinical benefits
 Foreign marketing history
 Chemistry, Manufacturing and control summary
 Nonclinical pharmacology and toxicology summary
 Human pharmacokinetics and bioavailability summary
 Microbiology summary
 Clinical data summary and results of statistical analysis
 Discussion of benefit/risk relationship
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12. CONTD....…
Section 4: Chemistry, manufacturing and controls
 Chemistry, manufacturing and control information
 Samples
 Methods validation package

Section 5: Nonclinical pharmacology and toxicology
 Provide individual study reports, including pharmacology,
toxicology, ADME studies.
 Effects related to the therapeutic indication, such as the
pharmacodynamic ED50 in dose- ranging studies and the
mechanism of act ion (if know n)
 Interactions with other drugs (or cross-reference the location
of the information in any of the above subsection 12

13. CONTD....
Section 6: Human Pharmacokinetics and bioavailability
 includes data from Phase I safety and tolerance studies in
healthy volunteers. Element in the section tabulated
summary of studies showing all in vivo biopharmaceutics
studies performed.
Summary of analytical method used in in vivo
biopharmaceutic study
Pilot or background studies
Bioavailibility or bioequivalence studies
Pharmacokinetic studies
In vitro studies 13

14. CONTD....
Section 7: Microbiology
Includes for anti infective drug products.
requires the following technical information and data:-
A complete description of the biochemical basis of the drug
action on microbial physiology
The drugs antimicrobial spectrum
Describe any known mechanism of resistance to the drug
and provide information/data of any known epidemiologic
studies demonstrating prevalence to resistance factor
Clinical microbiology laboratory methods
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15. CONTD....
 Section 8: Clinical data
Includes.
List of investigators and list of INDs and NDAs
Background or overview of clinical investigations
Clinical pharmacology
Controlled clinical trials
Uncontrolled clinical trials
Other studies and information
Integrated summary of effectiveness data
Integrated summary of safety information
Drug abuse and overdose information
Integrated summary of benefits and risks of drug 15

16. CONTD....
 Section 9: Safety data
Statements in draft labeling
Contraindications
Warnings
Precautions
Adverse events
 Section 10: Statistical data
All controlled clinical trial reports
Integrated efficacy and safety summaries
Integrated summary of risks and benefits
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17. CONTD....
Section 11: Case report tabulation
 include complete tabulation for each patient from every
adequately are well controlled phase II and Phase III
efficacy, clinical pharmacology study. It also tabulation of
safety data from all clinical studies.
Section 12: Case report forms
 include the complete CRF for each patient who died during
a clinical study or adverse event, regardless of whether the
AE is considered to be related to the study drug, even if the
patient was receiving a placebo or comparative drug.
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18. Contd…..
Application itself consists of a cover letter and a completed form
FDA-356h along with several other supporting items as
appropriate
Item 13: Patent information
Item 14: Patent certification
Item 15: Establishment description
Item 16: Debarment certification
Item 17: Field copy certification
Item 18: User fee cover sheet (Form FDA-3397)
Item 19: Financial disclosure (Form FDA 3454, form FDA-
3455)
Item 20: Other/pediatric use
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19. The NDA in CTD Format
Module 1 is not part of the CTD because it is not harmonized.
CTD NDA: 314.50
Module 1 a) Application form
c)2.1 Annotated text of proposed
labeling
e)Samples and Labeling
h)Patent information
i) Patent certification
j)Claimed exclusivity
Module 2 c)Summaries
d)5.7 Abuse potential
Module 3 d)1 CMC
Module 4 d)2 Nonclinical pharm/tox
Module d)3 Human PK
d)4 Microbiology
d)5 Clinical data
d)6 Statistical section
f) CRF and CRT 19

20. Abbreviated New Drug Application
(ANDA)
“A drug product that is comparable to a brand/reference listed drug
product in dosage form, strength, route of administration,
quality and performance characteristics, and intended use”
 termed "abbreviated" because they generally not required to
include preclinical (animal) and clinical (human) data to
establish safety and effectiveness.
 Basic Generic Drug Requirements are:--
 Same active ingredient(s)
 Same route of administration
 Same dosage form
 Same strength
 Same conditions of use
 Inactive ingredients already approved in a similar NDA 20

21. Goal of ANDA
 To reduce the price of the drug.
 To reduce the time development.
 Increase the bioavailability of the drug in comparison
to references list drug.
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22. ANDA Review process
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23. NDA vs. ANDA Review Process
NDA Requirement ANDA Requirement
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24. What is Bioequivalence?
A generic drug is considered to be bioequivalent to the
brand name drug if:
 The rate and extent of absorption do not show a
significant difference from listed drug, or
The extent of absorption does not show a significant
difference and any difference in rate is intentional or
not medically significant
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25. Patent Certification condition for
ANDA
Described in section 505(j)(2)(A)(vii) of the Act.
I Patent Not Submitted to FDA –
approval effective after OGD scientific determination
II Patent Expired –
approval effective after OGD scientific determination
III Patent Expiration Date (honored) –
tentative approval after OGD scientific determination,
final approval when patent expires
IV Patent Challenge –
tentative approval after OGD science determination, final
approval when challenge won
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26. Paragraph IV certification
According to section 505(j)(2)(B)(i), 2157 CFR
 The ANDA applicant must provide appropriate notice of a
paragraph IV certification to each owner of the patent that is
the subject of the certification and to the holder of the
approved NDA to which the ANDA refers
And by Section 505(j)(5)(B)(iv)
 An incentive for generic manufacturers to file paragraph IV
certifications and to challenge listed patents as invalid, or not
infringed, by providing for a 180-day period of marketing
exclusivity
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27. Patent Challenge Successful – Award of
180-Day Exclusivity Period
Awarded to first ANDA holder to file a complete
application with patent challenge
Protection from other generic competition – blocks
approval of subsequent ANDAs
Protection triggered by:
First commercial marketing
Forfeiture provisions
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28. Orphan Drug Exclusivity (ODE)
Orphan drug refers to a product that treats a rare disease -
affecting fewer than 200,000 Americans
7 years exclusivity
 Granted on approval of designated orphan drug
 OGD works with the Office of Orphan Products
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29. ANDA approval status
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30. CONCLUSION
NDA
ANDA
Applicable for new drug Applicable for generic drug
Take longer time ( 12-15 years) Compare to NAD less time
taken(1-2 years)
More expenditure of money Comparatively less
Cost of drugs are more Cost of drugs are less
Nonclinical studies and clinical
investigations are essential
Nonclinical studies and clinical
investigations are nonessential
except bioavailability and
bioequivalence
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31. REFERENCES
 Douglas J. Pisano $ David S. Manlus –FDA Regulatory Affairs, A
guide for Prescription Drugs, Medical Devices and Biologics-
New drug Application –Second edition-Marcel Dekker,inc- page
no 69-108.
 Richard A. Guarino- New Drug Approval process-1)The New
Drug Application, Content, Format 2) Abbreviated $
Supplementary New Drug Application- Fourth edition-Marcel
Dekker,inc- page no 113-183.
 Loyd V. Allen Jr, Nicholas G. Popovich, Howard C. ansel-Ansel’s
Pharmaceutical Dosage Forms and delivers systems- New Drug
Development and Approval Process-8th edition- B.I. publication-
Page no 25-65.
 http://www.fda.gov/cder/guidance/index.htm.
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32. THANK YOU
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