Considerations forLong-Term ClinicalNeurodevelopmentalSafety Studies inNeonatal ProductDevelopmentGuidance for IndustryDRAFT GUIDANCEThis guidance document is being distributed for comment purposes only.Comments and suggestions regarding this draft document should be submitted within 60 days ofpublication in the Federal Register of the notice announcing the availability of the draftguidance.Submit electronic comments to https://www.regulations.gov.Submit writtencomments to the Dockets Management Staff(HFA-305),Food and Drug Administration,5630Fishers Lane,Rm.1061,Rockville,MD 20852.All comments should be identified with thedocket number listed in the notice of availability that publishes in the Federal Register.For questions regarding this draft document,contact (OC)Office of Clinical Policy andPrograms,Office of Pediatric Therapeutics,Email:OPT@fda.hhs.gov,(CDER)Office ofCommunications,Division of Drug Information 301-301-796-3400,or(CBER)Office ofCommunication,Outreach and Development,800-835-4709 or 240-402-8010 or (CDRH)Officeof Policy Email:CDRH-Guidance@fda.hhs.gov
