FDA Filing/Approval

After adequate clinical data are collected, drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing through submitting the New Drug Application (NDA) to the agency. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the following: 1) the safe and effectiveness of the drug in its proposed use(s) when used as directed, and whether the benefits of the drug outweigh the risks; 2) how appropriate is the drug's proposed labeling; 3) application of Good Manufacturing Practice methods used in producing the drugs to maintain the drug’s identity, strength, quality, and purity. 

On this page you will find legal and ethical regulations and guidance that the US FDA published for the FDA filing, reviewing and approval of drug development:

New Drug Application (NDA) submission
New Drug Application (NDA) Process (CBER)

FDA Review
NDA Review Process - THIS IS OLD
Good Review Practices
U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook 

Next Page - GXPs for Drugs


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