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These FDA regulations required that manufacturers disclose possible dangers and side effects of their medicines is :
A. Kefauver-Harris Amendment
FDA regulations
These FDA regulations required that manufacturers disclose possible dangers and side effects of their medicines is Kefauver-Harris Amendment .
Medical Device Reporting (MDR) direction (21 CFR Portion 803) contains required prerequisites for producers, merchants, and gadget client offices to report certain device-related antagonistic occasions and item issues to the FDA.
Thus, the correct answer is A.
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