FDA Offers Draft Guidance on Dosing, Safety Issues for Pediatric Studies

The Food and Drug Administration issued draft guidance Dec. 9 on dosing and safety considerations for pediatric studies for drugs and biologics.

The guidance, titled “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products,” is intended to help sponsors of new drug applications (NDAs) and biologic license applications (BLAs) for therapeutic biologics and supplements to these applications who are planning to conduct clinical studies.

The guidance was announced in a Dec. 9 Federal Register notice (79 Fed. Reg. 73,079).

The FDA says that comments can be submitted at any time, but should be received ...