21 CFR §14.160

1. (a)Generally on the safety and effectiveness, including the labeling and advertising, and regulatory control of the human prescription drugs falling within the pharmacologic class covered by the advisory committee and on the scientific standards appropriate for a determination of safety and effectiveness in that class of drugs.
2. (b)Specifically on any particular matter involving a human prescription drug pending before FDA, including whether the available information is adequate to support a determination that—
   1. (1)A particular IND study may properly be conducted;
   2. (2)A particular drug meets the statutory standard for proof of safety and effectiveness necessary for approval or continued approval for marketing; or
   3. (3)A particular drug is properly classified as a new drug, an old drug, or a banned drug.