§ 312.86. Focused FDA regulatory research.
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/us/cfr/t21/s§ 312.86·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical, chemical/manufacturing, and clinical phases of drug development and evaluation. When initiated, FDA will undertake such research efforts as a means for meeting a public health need in facilitating the development of therapies to treat life-threatening or severely debilitating illnesses.