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What is RMW? Regulated medical waste (RMW), also known as âbiohazardousâ waste or 'infectious medicalâ waste, is the portion of the waste stream that may be contaminated by blood, body fluids or other potentially infectious materials, thus posing a significant risk of transmitting infection.
If both regulations are applicable, the one with the stricter conditions in an area would prevail. For example, FDA regulations do not allow for a waiver of inform consent for the conditions described in 45 CFR 46.116. If the study involves an FDA-regulated product, it is potentially an FDA-regulated study. The fact that the study you describe is mining data about patient response to medication prescribed as the practice of medicine does not change the fact that the product itself is FDA-regulated.