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Protocol Study ID: NN80224246 UTC: U111111853276 EU PAS No.: EUPAS23369CONFIDENTIALDate: Version: Status: Page:15 March 2019 6.0 Final 1 of 42Novo NordiskProtocolStudy ID: NN80224246 In market utilization
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Efficacy and safety refer to the effectiveness and risk assessment of a drug or treatment in achieving desired health outcomes while ensuring that the risks involved do not outweigh the benefits.
Pharmaceutical companies and manufacturers of medical products are required to file efficacy and safety data with regulatory agencies when seeking approval for their products.
Filling out efficacy and safety data typically involves conducting clinical trials, gathering data on the drug's effectiveness, potential side effects, and submitting detailed reports according to regulatory guidelines.
The purpose of assessing efficacy and safety is to ensure that a treatment is effective for its intended use and to identify any risks associated with its use, thereby protecting public health.
Information required includes clinical trial results, dosage information, side effects, demographic data on trial participants, and long-term effects of the treatment.
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