FDA Backs Nonclinical Trial Design for Osteoporosis Candidates

Drugmakers seeking approval of osteoporosis candidates should bolster their submissions with nonclinical pharmacology studies to determine adverse effects, the FDA advises.

In a draft guidance issued last week, the agency recommends that drugmakers conduct bone quality studies for osteoporosis candidates in addition to standard pharmacology and toxicology studies.

The agency says such studies are needed due to the long-term adverse effects pharmaceutical agents can have on bone quality and because there are no reliable methods for researching bone quality without using invasive means.