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Is assent required for both FDA and ICH guidelines?

  1. Yes, for both.

  2. No, only for FDA.

  3. No, only for ICH.

  4. Assent is not required for either FDA or ICH.

The correct answer is: Yes, for both.

Assent is required for both FDA and ICH guidelines because both organizations have regulations and requirements that must be followed in order to comply with their guidelines. While the other options may be partially correct, they do not encompass the full scope of the question. Option B states that only FDA requires assent, but this is not true as ICH also has its own set of guidelines that require assent. Option C states that only ICH requires assent, which is also incorrect as FDA has its own set of guidelines that require assent. Option D is not a complete or accurate answer as assent is indeed required for both FDA and ICH guidelines.