NEW DRUG APPLICATON

1. NDA
(New Drug Application)

2. Since 1938 in U.S.
A vehicle for approval of New Drugs

3. NDA is a …
• A formal proposal of Sponsor to the FDA for
the granting the Marketing & Sale Approval of
their new pharmaceutical.
• A narrative of the Drug
– Ingredients
– Manufacture, processing, packaging
– Non clinical data
– Clinical data
– P’cokinetics & dynamics

4. Why NDA???
• Safety & Efficacy, risk benefit ratio
• Proposed labeling (Package Insert)scrutinized
• Whether the methods used in manufacturing
the drug and the controls used to maintain the
drug's quality are adequate to preserve the
drug's identity, strength, quality, and purity.

5. 21CFR part 314
• Sub parts A to I
• subpart A: General Provisions
– Scope, Purpose & Definitions

6. Subpart B: Applications
 Content and format of an application.
 Notice of certification of invalidity or noninfringement of a patent.
 Submission of patent information.
 Procedure for submission of an application requiring investigations for
approval of a new indication for, or other change from, a listed drug.
 Pediatric use information.
 Amendments to an unapproved application.
 Withdrawal by the applicant of an unapproved application.
 Supplements and other changes to an approved application.
 Procedures for submission of a supplement to an approved application.
 Change in ownership of an application.
 Postmarketing reporting of adverse drug experiences.
 Other postmarketing reports.
 Waivers.

7. Contents & Format
Three copies of the application are required:
1. An archival copy,
2. A review copy, and
3. A field copy.

8. Contents & Format
An application form (Form FDA-356h)
An index,
A summary,
Five or six technical sections,
Case report tabulations of patient data, case report
forms,
Drug samples, and labeling, including, if
applicable,
Any Medication Guide required

9. FDA Review
• Review period -180 days
• Three possible outcomes from FDA-
– Approval Letter
– Approvable Letter
– Not Approvable Letter

10. Prescription Drug User Fee Act
(PDUFA)
• On November 21, 1997, The President signed
the Food and Drug Administration
Modernization Act of 1997. This legislation
includes authorization for FDA to continue to
collect three types of user fees from applicants
who submit certain new drug and biological
product applications.

11. NDA in India
Form 44

13. Requirements for the Drug Approval
in India
Has five Modules
1. Module I: Administrative/Legal Information
2. Module II: Summaries
3. Module III: Quality information (Chemical,
pharmaceutical and biological)
4. Module IV: Non-clinical information
5. Module V: Clinical information

14. Application Review Period
Remains the same as that of USFDA
____ days

15. Thank You
Any Questions to ask????
Or else
drop them in this mail id.
kavaderima@gmail.com