Assessing user fees under the biosimilar user fee amendments of 2017 Assessing user fees under the biosimilar user fee amendments of 2017

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, issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Publication: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018 Language(s): English Format: Text Subject(s): Biosimilar Pharmaceuticals -- economics Fees and Charges Investigational New Drug Application -- economics 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 (17 pages)). NLM Unique ID: 101734364 (See catalog record) Permanent Link: http://resource.nlm.nih.gov/101734364