How to prepare a pre-request for designation (pre-RFD)
- Series Title(s):
- Guidance for industry
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.
- [Silver Spring, Maryland] : Office of Combination Products, Office of the Commissioner, February 2018
- Equipment and Supplies -- classification Drugs, Investigational -- classification Investigational New Drug Application Pharmaceutical Preparations -- classification Humans United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Guideline Technical Report
- The National Library of Medicine believes this item to be in the public domain. (More information)
- 1 online resource (1 PDF file (15 pages))
- NLM Unique ID:
- 101734055 (See catalog record)