2. Introduction
The NDA application is the vehicle through which drug
sponsors formally propose that the FDA approve a new
pharmaceutical product for sale and marketing in the country.
The data gathered during the animal studies and human
clinical trials of an Investigational New Drug (IND) become part of
the NDA.
For decades, the regulation and control of new drugs in the
United States has been based on the New Drug Application (NDA).
Since 1938, every new drug has been the subject of an approved
NDA before U.S. commercialization.

3. Introduction
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.

4. New FDCs for approval for Marketing:
1) One or more of the active ingredients is a
Drug
2) Active drug is approved individually but
are combined for first time.
3)FDCs which are already marketed , but in which
it is proposed either to change the ratio of active
ingredients or to make a new therapeutic claim.
4)FDCs include those whose active ingredients
have been widely used in particular indications
for years their concomitant use is often
necessary and no claim is proposed to be made
other than convenience

6. Guidance Documents for NDAs
 Guidance documents represent the Agency's
current thinking on a particular subject.
 These documents are prepared for FDA review
staff and applicants/sponsors to provide
guidelines to the processing, content, and
evaluation/approval of applications and also to
the design, production, manufacturing, and
testing of regulated products.

7. Guidance Documents for NDAs
 They also establish policies intended to
achieve consistency in the Agency's
regulatory approach and establish inspection
and enforcement procedures. Because
guidances are not regulations or laws, they
are not enforceable, either through
administrative actions or through the courts.
 An alternative approach may be used if
such approach satisfies the requirements of
the applicable statute, regulations, or both.

8. Goals of the NDA
 The goals of the NDA are to provide enough
information to permit FDA reviewer to reach the
following key decisions:
 Whether the drug is safe and effective in its proposed
uses, and whether the benefits of the drug outweigh the
risks.
 Whether the drug's proposed labeling (package insert) is
appropriate, and what it should contain.
 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.

10.  Data required to be submitted with application for
permission to market a New Drug:
1)Introduction
Brief introduction of the drug and the therapeutic class it belongs.
2) Chemical and Pharmaceutical information.
 Information of active ingredients eg; Generic name , INN.
 Physiochemical Data eg; Chemical name , structure , emperical Formula
, mol wt.
Physical properties eg; Solubility , Rotation, Partition coefficient,
Dissociation constant.
 Analytiacal data eg;Elemental Analysis,Mass,NMR,IR,UV
spectra,Polymorphic identification.
 Complete Monograph Specification including eg; quantification of
impurities ,Enantiomeric purity,Assay.
 Dosage form and its composition.
 Specification of active and inactive ingredients.
 Outline of the method of the manufacture of the active ingredient.
 Stability Data.

11. Data required to be submitted with application for permission
to market a New Drug:
 Animal pharmacology
Summary
Specific pharmacological actions.
General pharmacological actions.
Follow up and Supplemental safety pharmacological studies
pharmaacokinetics: absorption,distribution,metabolism,excretion.
 Animal Toxicology
Genral aspects
Systemic toxicity studies
Male fertility studies
female Reproduction and developmental studies
local toxicity
Allergenicity/Hyper sensitivity
Genotoxicity
Carcinogenicity

12.  Human/Clinical pharmacology (Phase I)
Summary
Specific Pharmacological effects.
General Phamacological effects
Pharmacokinetics,absorption,distribution,metabolism,excretion
Pharmacodynamics/early measurement of drug activity
 Therapeutic exploratory trials (Phase II)
Summary
Study reports

13. Data required to be submitted with application
for permission to market a New Drug:
 Therapeutic confirmatory trials (Phase III)
Summary
Individual study reports with listing of sites and
Investigators.
 Special studies
Summary
Bio-availability/Bio-equivalence
Other Studies eg; geriatrics,paediatrics,pregnant or
nursing woman

14.  Regulatory status in other countries
Countries where the drug is
marketed
Approved
Approved as IND
Withdrawn if any with reasons.
Restrictions on use,if any,in countries where marketed.
Free sale certificate or certificate of analysis,as appropriate.

18. Refernces
 www.geradts.com
 www.law.duke.edu/journals/journalsource
 Regulations of Clinical Trials by Rakesh
Kumar Rishi,1st ed.