What was the rationale for the 1992 changes in the Food and Drug Administration's regulations to permit accelerated approval of drugs for the treatment of life-threatening or severely debilitat-ing disease?
a. To allow for marketing before completion of phase II of drug trials
b. To ensure that the unknown risks associated with early approval are balanced by the need for effective drugs
c. To change the rules because existing FDA regulations were too stringent for po-tentially effective drugs
d. To accelerate approval of new drugs to give prescribers the option of using them without research findings
B
Accelerated drug approval was needed to ensure that effective drugs necessary for life-threatening and/or severely debilitating diseases were available but with a balance of bene-fit/effectiveness and risk.
Phase II drug trials are related to the therapeutic utility and dosage range, not to accelerated ap-proval of drugs.
FDA regulations were not stringent enough, but became so over time to protect consumers.
Accelerated approval of new drugs did not give prescribers the option to use them without re-search findings. Drugs are approved only after a rigorous clinical trial and research process.
DIF: Cognitive Level: Comprehension REF: pp. 15-17
TOP: Nursing Process: Diagnosis
MSC: NCLEX Client Needs Category: Physiological Integrity: Reduction of Risk Potential
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