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What is the summary of safety and effectiveness?

It summarizes data relevant to safety in the intended population, integrating the results of individual clinical study reports as well as other reports such as the integrated analyses of safety performed in the ISS. The SCE provides a comprehensive overview of the efficacy of the drug.

What is FDA safety?

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nations food supply, cosmetics, and products that emit radiation.

What is the FDA in Canada?

Health Canada : Health Canada is responsible for protecting human and animal health and the safety of Canadas food supply. International Counterparts - FDA fda.gov about-fda cvm-offices internat fda.gov about-fda cvm-offices internat

What is safety and effectiveness?

What does safe and effective mean? The phrase safe and effective was adopted by the Food and Drug Administration (FDA) to indicate that a drug or device has met their standards and can be sold and marketed in the United States.

What is the FDA summary of safety and effectiveness data?

The SSED is an FDA document intended to present a reasoned, objective, and balanced summary of the scientific evidence, both positive and negative, that served as the basis of the decision to approve or deny the PMA.

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