1. New Drug Application(NDA) Vs Abbreviated new drug application (ANDA)

2. Contents a) Introduction. b) Goal of NDA c) Classification of NDA
 1.New Drug Application(NDA)
a) Introduction.
b) Goal of NDA
c) Classification of NDA
d) New drug development review
e) The NDA in CTD Format
2. Abbreviated new drug application(ANDA)
a) Introduction
b) Goal of ANDA
c )Patent certification condition
3. Conclusion. 
4. References.

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

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

5. New Drug Development and Review Process Steps from Test Tube to New Drug Application Review

6. Phases of clinical testing
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

9. NDA Review Process

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.

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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.

18. 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

19. The NDA in CTD Format Module 1 is not part of the CTD because it is not harmonized
Application form
c)2.1 Annotated text of proposed labeling
e)Samples and Labeling
h)Patent information
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

20. 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”
It 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

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.

22. ANDA Review process

23. NDA vs. ANDA Review Process
NDA Requirement
ANDA Requirement

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

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 –
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

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

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

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

29. ANDA approval status

30. CONCLUSION Applicable for new drug Applicable for generic drug
NDA
ANDA
Applicable for new drug
Applicable for generic drug
Take longer time ( 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

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
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
Loyd V. Allen Jr, Nicholas G. Popovich, Howard C. Ansel’s Pharmaceutical Dosage Forms and delivers systems- New Drug Development and Approval Process-8th edition- B.I. publication- Page no

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