New Drug Application

Presented By: Amey Deshpande

 Overview
1. What is NDA?
2. Goals of NDA
3. Process of NDA in Brief
4. Investigational New Drug (IND)
5. Process of IND
6. Clinical Trials
7. Clinical Trials, IND and NDA
8. The actual application
9. NDA Process
10. Requirements for similar products
11. ANDA Process
 What is NDA?
The New Drug Application (NDA) is the
procedure through which drug
sponsors formally propose the FDA
to approve a new pharmaceutical for
sale and marketing
 Goals of NDA
The goals of the NDA are to provide enough
information to FDA to establish the following:
1.safety and efficacy of drug in its proposed use
when used as directed
2. benefits of the drug outweighs the risks
3. the drug’s proposed labeling is appropriate,
and has what it should contain
4.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
 Process of NDA in Brief

Advisory committee
 Investigational New Drug (IND)
• To legally test the drug on human subjects,
the maker must first obtain an Investigational
New Drug (IND) approval from FDA
• This application is based on pre-clinical
data, typically from animal studies, that
shows the drug is safe enough to be
tested in humans
• Often the "new" drugs that are submitted are
not new molecular entities, but old
medications that have been modified
Process
of IND
 Clinical Trials
The trials are typically conducted in following phases:
• Phase 1: The drug is tested in a small (20-50)
group of healthy volunteers for toxicity (Safety)
• Phase 2: Safety and Efficacy testing
• Phase 3: The drug is typically tested in double-
blind, placebo controlled trials to demonstrate
that it works
**Sponsors typically confer with FDA prior to starting
these trials to determine what data is needed, since
these trials often involve hundreds of patients and
are very expensive
• Phase 4: These are post-approval trials that are
sometimes a condition attached by the FDA to the
approval
Clinical Trial, IND and NDA
 The actual application
• The results of the testing program are entered in an
FDA-approved public document that is called the
product label,
• 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 formulation are
– the results of the animal studies,
– how the drug behaves in the body
– and how it is manufactured, processed and packaged.
• Once approval of an NDA is obtained, the new drug
can be legally marketed starting that day
 NDA
Process
Requirements for similar products
• Biologics, such as vaccines are generally
approved by FDA via a Biologic License
Application (BLA), rather than an NDA
• Generic drugs that have already been approved
via an NDA submitted by another maker are
approved via an
Abbreviated New Drug Application (ANDA), which
does not require all of the clinical trials normally
required for a new drug in an NDA.
• Medical devices are approved by a variety of
methods depending on the class of the device. A
Pre-market Application (PMA) largely equivalent
to an NDA
ANDA
Process
 Any Questions??...

Thank You!!