👤 Person
New Drug Application
Request US FDA approve new medications
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📌 Topics
- Pharmaceutical Development (1)
- Ophthalmology (1)
- Regulatory Approval (1)
🏷️ Keywords
Opus Genetics (1) · FDA approval (1) · Presbyopia treatment (1) · Phentolamine ophthalmic solution (1) · New Drug Application (1) · Age-related farsightedness (1) · Biopharmaceutical (1)
📖 Key Information
The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful.
The goals of the NDA are to provide enough information to permit FDA reviewers to establish the complete history of the candidate drug.
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Food and Drug Administration · 1 shared articles