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HARPETH PEDIATRICS New RSV (Beyfortus) an4body treatment1 dose of nirsevimab (Beyfortus) for all infants younger than 8 months born during or entering their rst RSV season.1 dose of nirsevimab (Beyfortus)
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FDA approval of a new drug is the process by which the Food and Drug Administration evaluates and authorizes a new pharmaceutical product for sale and use in the United States after confirming its safety and efficacy.
Pharmaceutical companies or sponsors who develop new drug products are required to file for FDA approval to ensure they meet the necessary safety and efficacy standards.
To fill out the application for FDA approval of a new drug (NDA), a sponsor must compile clinical trial data, manufacturing details, labeling information, and proposed use instructions, and submit it in the appropriate format through the FDA's electronic submission system.
The purpose of FDA approval for a new drug is to ensure public safety by assessing the drug's safety, efficacy, and quality before it can be marketed and sold.
The information that must be reported includes the drug's chemistry, manufacturing processes, clinical trial results, proposed labeling, and any potential side effects.
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