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KEY THERAPEUTIC UPDATES: BREAST CANCER, HEPATITIS C, MULTIPLE SCLEROSIS | ACRE#: 0178000018102H01P1. What type of breast cancer is Kigali (ribociclib)
FDA indicated to treat?
a. HR+/HER2 premenopausal
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What is FDA approves new option?
FDA approves new option refers to the process by which the U.S. Food and Drug Administration grants approval for a new drug, treatment, or medical device that has met specific safety and efficacy standards.
Who is required to file FDA approves new option?
Pharmaceutical companies, medical device manufacturers, and sponsors of new medical treatments are required to file for FDA approvals for their products.
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Filling out the FDA approves new option involves submitting an application, which typically includes detailed information on the product, clinical trial data, manufacturing processes, and labeling information in accordance with FDA guidelines.
What is the purpose of FDA approves new option?
The purpose of FDA approval is to ensure that new medical products are safe and effective for public use before they can be marketed.
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Information that must be reported includes clinical trial results, product formulation, manufacturing details, and proposed labeling.
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