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TEPEZZA INFUSION & MEDICAL CENTER_________1. Patient NameDOBPatient Phone/Cell #Patient demographic and insurance information to be faxed with Infusion Order Form2. Medical Information (Please select
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The FDA's approval of the first treatment refers to the official authorization granted by the Food and Drug Administration for a new therapeutic option to be marketed and used in the United States. This approval ensures that the treatment has undergone rigorous testing for safety and efficacy.
Pharmaceutical companies or sponsors seeking to introduce a new treatment are required to file for FDA approval. This includes submitting data from clinical trials demonstrating the treatment's safety and effectiveness.
To file for FDA approval, a company must complete a New Drug Application (NDA) or Biologics License Application (BLA) which includes detailed information on the drug’s research, clinical trial results, manufacturing practices, labeling, and proposed usage.
The purpose of FDA approval for a treatment is to ensure that it is safe and effective for its intended use, thereby protecting public health by allowing only suitable therapies to reach the market.
Information that must be reported includes clinical trial results, manufacturing processes, safety and efficacy data, labeling proposals, and any potential side effects or risks associated with the treatment.
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