Which of the following is the most accurate statement about the FDA's expedited review of drugs?
Group of answer choices
Inclusion in the breakthrough drug category implies only that the drug has the potential to treat a serious condition.
Approval of drugs under expedited review procedures imply the need for continued collection of safety and efficacy data post approval.
There is only one category of expedited review of drugs.
Expedited review of drugs does not allow the use of surrogate endpoints to evaluate the efficacy of drugs.
The most accurate statement about the FDA's expedited review of drugs are Inclusion in the breakthrough drug category implies only that the drug has the potential to treat a serious condition and approval of drugs under expedited review procedures imply the need for continued collection of safety and efficacy data post approval.
Which of the following is the most accurate statement about the FDA's expedited review of drugs?...
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