How to prepare a pre-request for designation (pre-RFD) How to prepare a pre-request for designation (pre-RFD)

Collection: Health Policy and Services Research Series Title(s): Guidance for industry Contributor(s): United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration. Office of the Commissioner. Office of Medical Programs and Tobacco. Office of Combination Products, issuing body. Publication: [Silver Spring, Maryland] : Office of Combination Products, Office of the Commissioner, February 2018 Language(s): English Format: Text Subject(s): Equipment and Supplies -- classification Drugs, Investigational -- classification Investigational New Drug Application United States United States. Department of Health and Human Services United States. Food and Drug Administration Genre(s): Guideline Technical Report Copyright: The National Library of Medicine believes this item to be in the public domain. (More information) Extent: 1 online resource (1 PDF file (15 pages)) Illustrations: Illustrations NLM Unique ID: 101734055 (See catalog record) Permanent Link: http://resource.nlm.nih.gov/101734055