FDA Issues Draft Guidance for Industry On Endocrine System Studies for Drugs

The Food and Drug Administration announced the availability of a draft guidance for industry on studies to determine whether a drug disrupts the endocrine system, according to a notice published in the Sept. 20 Federal Register (78 Fed. Reg. 57,859).

The draft guidance, “Endocrine Disruption Potential of Drugs: Nonclinical Evaluation,” provides recommendations to sponsors on the parameters that should be routinely assessed in toxicology studies for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) to determine the potential for a drug to disrupt the endocrine system, the agency said.

The ...