Evaluation of unanticipated adverse device effects (UADDEs) must be reported to the FDA by the IRB and all investigators participating in the test of the product within ten working days.
<h3>What is IRB and FDA?</h3>
The full meaning of IRB is Institutional Review Board, while the full meaning of FDA is the United States Food and Drugs Administration - a Federal Agency.
The above bodies are responsible for protecting American citizens from harmful products.
Learn more about FDA and IRB at;
brainly.com/question/17432443
#SPJ11
Answer:
Federalism is the system of government in which sovereignty is constitutionally divided between a central governing authority and constituent political units. It is based upon democratic rules and institutions in which the power to govern is shared between national and state governments, creating a federation.
Explanation:
Hope This Helps!!!
Answer:
C. Lack of a bill of rights in the new constitution is problematic is the correct answer.
Explanation:
The Anti Federalists were the politicians who were against the US constitution which was adopted in 1787. They considered the constitution to be giving too much power to the central government and they were afraid of giving too much power to single national government as the government could infringe upon the rights of citizens and states. Patrick Henry, James Winthrop and George Mason were some of the famous Anti federalists. They were afraid of the new constitution because the states were given more power in Articles of Confederation and Perpetual Union while it wasn't so in the new constitution. Their influence led to the passage of bill of rights. They wanted to establish a weak Central government as was in Articles of Confederation and wanted for strong central governments.
<span>Great Britain, Africa, New England, Virginia, and North Central.</span>
