FDA revisits botanical drug pathway amid ongoing challenges for clozapine and pig kidney research

The Food and Drug Administration is taking another look at the regulatory pathway for botanical drugs, signaling renewed interest in how plant‑derived therapies can be evaluated and approved.

At the same time, clinicians continue to face significant hurdles in prescribing clozapine, the most effective medication for treatment‑resistant schizophrenia, due to strict safety monitoring requirements and limited access.

Researchers are also exploring the use of pig kidneys as a temporary bridge to human transplantation, with early studies suggesting the approach could expand the donor pool while long‑term solutions are developed.