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;
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Answer:
close reading
Explanation:
Closer reading in literary criticism is the deliberate, continuous comprehension of a short section from a text. A close reading emphasizes the individual and the particular over the general, achieved by paying close attention to specific words, the grammar, the sequence in which the phrases reveal concepts, and the systematic frameworks. Thus we can conclude that the given case relates to close reading.
Answer:
Fourth amendment
Explanation:
The Department of Justice wants access to the telephone records of a major newspaper. The requirement for a search warrant (an order from a judge authorizing the search of the records) would be required under the <u>fourth amendment</u>.
The fourth amendment rights guarantees Americans the right to be secure in their homes and properties and protects them against unreasonable searches and seizures of properties by the police or any other government agency without probable cause or valid reasons. For a judge to issue a search warrant, there must be sufficient reason or probable clause else the affected individual can sue for a breach of his or her fourth amendment rights.
Answer:
Admiralty and maritime
Law and Equity
Affecting Ambassadors
Explanation:
The judicial Power shall extend to all Cases, in Law and Equity, arising under this Constitution, the Laws of the United States, and Treaties made, or which shall be made, under their Authority;--to all Cases affecting Ambassadors, other public Ministers and Consuls;--to all Cases of admiralty and maritime.
