COMPARING DRUGS & DEVICES: HOW ARE THE CLINICAL TRIALS REGULATED?

| July 27, 2017

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Once it is determined that a clinical trial is necessary, the applicable investigational new drug or medical device regulations will need to be followed. The regulatory requirements for conducting a clinical trial are exactly the same for drugs and devices when it comes to electronic medical records (21 CFR 11), human subject protection (21 CFR 50), financial disclosure (21 CFR 54), and IRB requirements (21 CFR 56). The differences exist in the investigational new drug regulations (21 CFR 312) and the investigational device exemption regulations (21 CFR 812); however, even within 21 CFR 312 and 21 CFR 812, the similarities far outweigh the differences. Some of those differences are described in the tables below.

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Cifarma Científica Farmacêutica LTDA.

Cifarma is a genuinely Brazilian company that was born in Santa Luzia (MG). Founded in 1999 in the era of globalization and with the need to combine technology with humanistic values. In 2002 the company inaugurated its new industrial park installed in an area of ​​100,000 m², in Goiânia (GO), a strategic region for the distribution of its products throughout the country.

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Cifarma is a genuinely Brazilian company that was born in Santa Luzia (MG). Founded in 1999 in the era of globalization and with the need to combine technology with humanistic values. In 2002 the company inaugurated its new industrial park installed in an area of ​​100,000 m², in Goiânia (GO), a strategic region for the distribution of its products throughout the country.

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