General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry

General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry guidance is intended to assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and supplements to such applications who are planning to conduct clinical studies in neonatal populations. This guidance provides recommendations for neonatal clinical pharmacology studies, whether the studies are conducted pursuant to section 505A of the Federal Food, Drug, and Cosmetic Act (FD&C Act),  section 505B of the FD&C Act, or neither.