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Legacy Day Treatment Unit Providers OrdersPatient Name: Date of Birth:Adult Ambulatory Infusion Order (STEWART) for Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)Med. Rec. No

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What is long-term effectiveness and safety?

Long-term effectiveness and safety refer to the assessment of the enduring impact and safety profiles of a product or medical intervention over an extended period, typically beyond the initial clinical trials.

Who is required to file long-term effectiveness and safety?

Manufacturers, researchers, or entities responsible for a product's post-market surveillance or clinical studies are typically required to file long-term effectiveness and safety.

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Filing long-term effectiveness and safety requires gathering relevant data, completing designated forms provided by regulatory authorities, and ensuring all information is accurate and comprehensive.

What is the purpose of long-term effectiveness and safety?

The purpose is to monitor and evaluate the sustained efficacy and safety of a product to protect public health and guide future medical decisions.

What information must be reported on long-term effectiveness and safety?

Information includes patient outcomes, adverse events, long-term side effects, product performance data, and any relevant clinical study results.

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