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

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
Pharmaceutical Preparations -- classification
Humans
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)
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
Pharmaceutical Preparations -- classification
Humans
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)