Clinical Investigation of Neuraxially Administered Drugs: A Regulatory Perspective

The Neurological Safety of an Epidurally Administered Lipo-PGE1 Agonist in Rats

“…6,16,17 Another advantage is its selective delivery to the appropriate spinal level. Lipo-PGE1 agonists are expected to be very efficacious when administered to the area directly adjacent to the spinal cord.…”

Labor Analgesia: Is There an Ideal Technique?

“…These pathways require continued investigation into neuraxial drug administration. In a separate editorial in this issue of the journal, Schultheis et al 9 from the Food and Drug Administration describe issues involved in the human study of new neuraxial drugs or formulations. Federal regulations require institutional review boards to institute additional safeguards before approving research involving pregnant women and fetuses.…”