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Page 1 of 601POSTAUTHORISATION SAFETY STUDY INFORMATIONVERTEX PHARMACEUTICALS INCORPORATED Title Observational Study to Evaluate the Long term Safety of Ivacaftor in Patients With Cystic FibrosisVersion

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What is long-term safety and efficacy?

Long-term safety and efficacy refer to the assessment of a treatment's safety and effectiveness over an extended period, typically involving monitoring side effects and health outcomes for a significant duration after treatment initiation.

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

Manufacturers and sponsors of pharmaceutical products or medical devices are required to file long-term safety and efficacy data as part of their regulatory obligations.

How to fill out long-term safety and efficacy?

To fill out long-term safety and efficacy reports, it is essential to collect and analyze clinical data, including patient follow-up information, adverse event reports, and health outcomes, and then submit this information according to regulatory guidelines.

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

The purpose of long-term safety and efficacy is to ensure that a treatment remains safe and effective over time, helping to identify any potential long-term side effects or changes in effectiveness that may arise after initial approval.

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

Information that must be reported includes adverse events, treatment effectiveness data, patient demographic data, and any changes in the patient's condition or health related to the treatment.

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