The Food and Drug Administration (FDA) regulates the
distribution of Gensol. The FDA is a federal executive
agency. It has rules about off-label marketing of drugs. In
order for the FDA's rule to hold the weight of law, it
must:
always hold formal hearings.
be approved by Congress.
O adopt any recommendations by the public on the
proposed rule.
publish notice of the proposed rule and allow for
comments before final publication.