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This document contains the FDA's review and concurrence regarding the Patient Package Insert (PPI) for Osphena (ospemifene) oral tablets, which are indicated for the treatment of vulvar and vaginal
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What is center for drug evaluation?
The center for drug evaluation is the organization responsible for evaluating and regulating drugs for safety and efficacy.
Who is required to file center for drug evaluation?
Pharmaceutical companies and drug manufacturers are required to file center for drug evaluation.
How to fill out center for drug evaluation?
Filling out center for drug evaluation requires providing detailed information about the drug, clinical trials, manufacturing processes, and safety data.
What is the purpose of center for drug evaluation?
The purpose of center for drug evaluation is to ensure the safety and effectiveness of drugs before they are approved for public use.
What information must be reported on center for drug evaluation?
Center for drug evaluation requires reporting information such as drug formulation, manufacturing process, clinical trial results, adverse events, and labeling information.
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