What Is Involved in a New Drug Application?
Submission of a new drug application (NDA) involves the compilation of information from many disciplines and sources. This information may be derived from recent work or may entail many lifetimes of development and records. In order to review an NDA completely and in a timely manner, the Food and Drug Administration (FDA) requires submissions to comply with the provisions set forth in the Code of Federal Regulations (1).
KeywordsDrug Product Drug Substance Case Report Form Drug Application Environmental Impact Assessment
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