New Drug Application (NDA) IND| Introduction | Importance | Types Classification |

New Drug Application (NDA) is an application submitted to U.S.FDA for permission to market a new drug product in the united states.
The goals of the NDA are to provide enough information to permit FDA reviewers to establish the following:
1. Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks?
2. Whether the drug’s proposed labelling appropriate, and what should it contain?
3. Are the methods used in manufacturing (Good Manufacturing Practices; GMP) of 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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