NDA is an important component of approval process. It provides following information and data for review. 1. Chemical and Pharmaceutical data. 2. Information and data of Phase I, Phase II and Phase III of clinical trials. 3. Information and data of preclinical studies. 4. Samples and testing protocols. 5. Prescribing information

1. NEW DRUG
APPLICATION
Prepared & presented by
Priyanka Deshmukh

2.  Regulation and control of new drug in United
States (U.S.) is based on NDA.
 Before marketing new drug in U.S. the sponsor or
drug manufacturer has to submit new drug
application (NDA) to "U.S.
 NDA is an important component of approval
process. It provides following information and
data for review.
NDA: NEW DRUG APPLICATION

3. Contents of NDA
1. Chemical and
Pharmaceutical data.
2. Information and data of
Phase I, Phase II and
Phase III of clinical
trials.
3. Information and data of
preclinical studies.
4. Information and data of
special studies in
geriatrics, paediatrics,
pregnant or nursing
women.
5. Regulatory status in other
countries.
6. Prescribing information.
7. Samples and testing
protocols.
8. Proposed packaging and
labelling details.

4. Main goals of NDA
1. Whether the drug is safe and efficacious in its
proposed intended use(s), and whether the benefits
of the drug balance the risks.
2. Whether the drug's proposed labelling (package
insert) is appropriate, and what it should contain.
3. 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. On receipt of NDA, the FDA directs it to the
therapeutic review division.
Within 60 days FDA determines, whether NDA is
adequate for review. FDA refuses to file inadequate
application and informs the sponsor accordingly.
After filing of application teams of experts and
advisory committee:
1 . review application,
2. inspect manufacturing site,
3. inspect clinical trials site.

6. The product may be marketed
in U.S., if NDA is approved by
U.S. FDA. After approval new
drug is listed in FDA's approved
drug products orange book.

7. THANK
YOU