New drug application

(NDA)

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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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Since 1938, every new drug or therapy has been the
subject of an approved NDA before US
commercialization.
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
are, the results of the animal studies, how the drug
behaves in the body, and how it is manufactured,
processed and packaged.
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 Goals of NDA

 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

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When will we go for NDA

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 OBJECTIVES
Provide enough information to permit FDA reviewers to establish
the following:
Risk Benefit

 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 (Good

Manufacturing Practice, GMP) the drug and the
controls used to maintain the drug’s quality adequate to
preserve the drug’s identity, strength, quality, and
purity?
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 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
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 NDA CONTENTS

NDA
SECTION 1 Index

NDA
SECTION 2 Labelling

NDA
Application summary
SECTION 3

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NDA CONTENTS

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

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NDA CONTENTS

NDA
SECTION Clinical microbiology
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NDA
Clinical data
SECTION 8

NDA
Safety update reports
SECTION 9

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NDA CONTENTS

NDA
SECTION 10 Statistics

NDA Case reports tabulations

SECTION 11

NDA
Case Report Forms(CRFs)
SECTION 12

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NDA CONTENTS

NDA
SECTION Patent information
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NDA
SECTION Patent certification
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NDA
SECTION Establishment description
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NDA CONTENTS

NDA
Debarment certificate
SECTION 16

NDA
Field copy certification
SECTION 17

NDA
User fee coversheet
SECTION 18

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NDA CONTENTS

NDA
SECTION Financial disclosure
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NDA
SECTION Other
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Review of NDA process

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 ADMINISTRATIVE REQUIREMENTS

Requirements US
Application ANDA\NDA
Debarment Required
Classification
Number of 3
copies
Approval ~18 Months
Time period
Fees Approximately
$52,000 for ANDA Application
&
Up to $2 million for NDA
Application

Presentation eCTD & Paper 16

 Requirements US

Justification ICH Q6A

Assay 90-100%

Disintegration Not Required

Colour Identification Not Required

Water Content Required

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Requirement
A) No of - Before 1985- 3 copies & now only 2
copies copies.
Archival copy
1)Archival copy Review copy
- Reference copy for FDA ( i.e. retained by FDA )
- Locate information not contained in review copy
2)Review copy
- Divided in to five or six section containing technical
and scientific information separately bound
- It contains copy of cover letter, application form, overall summary,
index, specific review section

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B) Assembling the application
1) Folder
- Color folder
Eg. archival copy - blue
chemistry section – red
- Name of applicant and name of drug product
- NDA no. if known
2) Paper size and binding
- Page 8.5 – 11 inches
- Bound at left side
- Use both side
- Accurately no.
3) Pagination – page no of both copy should have
same

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4) Volume size and identification
- Not more than 2 inches thick
- Should have name of applicant, drug
and
- NDA no.
5) Packing carton
- Box size 14 -12- 9.5 inches

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FDA – APPROVAL PROCESS

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 FAST TRACK APPROVAL

DRUGS FOR
 Serious disease

 Fill an unmet medical need

 Must be requested by the drug company

 FDA -60 days – review – decision

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 ACCELERATED APPROVAL
 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

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 PRIORITY REVIEW
 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 )

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