Presentation which covers the complete process for New drug application filling

1. NEW DRUG APPLICATION
PRESENTED BY
NISHU YADAV
M. PHARM ( Ist semester )
DEPARTMENT OF PHARMACEUTICS

2. CONTENT
 What is NDA
 Goals of NDA
 When will we go for NDA
 NDA forms
 Contents of NDA
 Guidance document for submission of NDA
 Submission of NDA
 Reviews & Approval of NDA

3. NEW DRUG APPLICATION
 Since 1938 ,every new drug has been the subject of an approved
NDA before U.S. commercialization
 NDA – Is formal final step taken by a drug sponsor ,which involves
applying to the Food and Drug Administration (FDA) to get approval
required to market
 Data gathered during the animal studies & human clinical trials of an
Investigational New Drug (IND) become part of the NDA

4.  Patent and manufacturing information
 Drug safety and specific effectiveness for its
proposed uses when used as directed
 Drug susceptibility to abuse
 Proposed labelling and directions for use
 Reports on design , compliance & conclusion of
completed clinical trials by institutional review board
Goals of NDA

5. When will we go for NDA

6. NDA FORMS & ELECTRONIC SUBMISSION
 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 ]
Guidance documents for electronic submissions

7. NDA CONTENTS
 NDA have about 20 different sections in addition to
the form FDA -356 h itself
 The specific contents of the NDA will depend on the
Nature of the drug product and the information
available at the time of submission of the
application
 Form FDA -356 h work as checklist as well as
certification that , the sponsor agrees to comply
with a range of legal and regulatory requirements

8. NDA CONTENTS
NDA
SECTION 1 Index
NDA
SECTION 2 Labelling
NDA
SECTION 3
Application summary

9. NDA CONTENTS
NDA
SECTION 4
Chemistry ,
manufacturing and
controls (CMC)
NDA
SECTION
5
Nonclinical pharmacology
and toxicology
NDA
SECTION
6
Human pharmacokinetics and
bioavailability

10. NDA CONTENTS
NDA
SECTION
7
Clinical microbiology
NDA
SECTION 8
Clinical data
NDA
SECTION 9
Safety update reports

11. NDA CONTENTS
NDA
SECTION 10 Statistics
NDA
SECTION 11
Case reports tabulations
NDA
SECTION 12
Case Report Forms(CRFs)

12. NDA CONTENTS
NDA
SECTION
13
Patent information
NDA
SECTION
14
Patent certification
NDA
SECTION
15
Establishment description

13. NDA CONTENTS
NDA
SECTION 16
Debarment certificate
NDA
SECTION 17
Field copy certification
NDA
SECTION 18
User fee coversheet

14. NDA CONTENTS
NDA
SECTION
19
Financial disclosure
NDA
SECTION
20
Other

15. NDA SECTION 3:APPLICATION SUMMARY
 This is an abbreviated version of the entire application
 It should give reviewers a clear idea of the drug and its
application
 The summary usually compries of 50 to 200 pages
NDA SECTION 4: Chemistry , manufacturing and controls
first technical section of the NDA it includes information
The three main elements are
chemistry , manufacturing and controls information
samples (submit only upon FDA’s request)
Methods validation package

16. CMC – DRUG SUBSTANCE
 Description
 Physical and Chemical characteristics
 Structural elucidation
 Drug substance manufacturing methods
 Drug substance analytical controls
 Drug substance stability

17. CMC – DRUG PRODUCT
 List of all components
 Drug products manufacturing methods
 Drug products packaging
 Drug product stability

18. NDA SECTION 7 : CLINICAL MICROBIOLOGY
 Required for anti infective drug products
 Biochemical basis of the drug’s action on microbial
physiology
 Drugs anti microbial spectrum
 Mechanisms of resistance to the drug
 Clinical microbiology laboratory methods

19. NDA SECTION 11: CASE REPORT TABULATION
 Complete tabulations for each patient from phase II and phase
III study
 Phase I clinical pharmacology study
 Safety studies
NDA SECTION 12 : CASE REPORT FORMS
 CRF for each patients who died during a clinical study
 Patients who were dropped from the study

20. GUIDANCE DOCUMENTS FOR NDAS
 BA and BE studies for orally administered drug
products
 Formatting , assembling and submitting new drug
and antibiotics application
 Format and content of CMC section of an
application
 Format and content of microbiology section of an
application
 Format and content of clinical and statistical section
of an application
 Container closure system for packing human drugs
and biologics

21.  Submitting documentation for the stability of human
drugs and biologics
 Format and content of human pharmacokinetics
and bioavailability section of an application
 Drug master files (DMF)
 NDAs – impurities in drug substances
 Required specifications for FDA’s IND,NDA, ANDA
drug master file binders
 Refusal to file

22. COMMON TECHNICAL DOCUMENTS
 In 1997 the FDA’s CDER, Published guidelines that allow
sponsors to submit NDAs electronically instead of on paper
THE CTD Triangle

23. ASSEMBLING APPLICATION FOR SUBMISSION

24.  The cover letter
 Form FDA – 356h
 The administrative sections
 Comprehensive NDA index
 Four copies of labelling section
 Three copies of CMC , methods validation package
 Case report tabulation & case report forms
Archival Copy

25.  THE COVER LETTER
 Form FDA -356h
 The administrative section
 Comprehensive NDA – index
 The labelling section
 The application summary
REVIEW COPY

26. REVIEW OF NDA

27. FDA – APPROVAL PROCESS

28. DRUGS FOR
 Serious disease
 Fill an unmet medical need
 Must be requested by the drug company
 FDA -60 days – review – decision
FAST TRACK APPROVAL

29.  In 1992 FDA instituted Accelerated approval
regulation
 Based on a surrogate endpoint , not the clinical end
point
 A surrogate endpoint is a marker – a laboratory
measurement , or physical sign – that is used in
clinical trails as an indirect or substitute
measurement that represents a clinically
meaningful outcomes , such as survival or symptom
improvement
ACCELERATED APPROVAL

30.  A Priority Review designation is given to those
drugs that offer major advances in treatment
 The goal for completing a priority review is six
months
 Given for those drugs use to serious / non serious
 Standard review is applied to a drug that offers a
most , only minor improvement over existing
marketed therapies ( 10 months for approval )
PRIORITY REVIEW

31. REFERENCE
 “ The Drug Development Process” U S Food and
Drug administration ,Jan 4 , 2018 ,retrieved May 1
, 2018
 http: // www. FDA .gov .
 www. Slideshare . Net

32. THANK YOU