
<oai_dc:dc xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:oai_dc="http://www.openarchives.org/OAI/2.0/oai_dc/" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://www.openarchives.org/OAI/2.0/oai_dc/ http://www.openarchives.org/OAI/2.0/oai_dc.xsd">
  <dc:title>Assessing user fees under the Biosimilar User Fee Amendments of 2017</dc:title>
  <dc:title>Guidance for industry</dc:title>
  <dc:subject>United States. Department of Health and Human Services</dc:subject>
  <dc:subject>United States. Food and Drug Administration</dc:subject>
  <dc:subject>Biosimilar Pharmaceuticals -- economics</dc:subject>
  <dc:subject>Drug Development -- economics</dc:subject>
  <dc:description>Revision 1</dc:description>
  <dc:publisher>Silver Spring, MD : Center for Drug Evaluation and Research, January 2020</dc:publisher>
  <dc:contributor>United States. Department of Health and Human Services, issuing body.</dc:contributor>
  <dc:contributor>United States. Food and Drug Administration, issuing body.</dc:contributor>
  <dc:contributor>Center for Biologics Evaluation and Research (U.S.), issuing body.</dc:contributor>
  <dc:contributor>Center for Drug Evaluation and Research (U.S.), issuing body.</dc:contributor>
  <dc:type>Technical Report</dc:type>
  <dc:format>Text</dc:format>
  <dc:format>1 online resource (1 PDF file (16 pages, 5 unnumbered pages)).</dc:format>
  <dc:identifier>nlm:nlmuid-101767621-pdf</dc:identifier>
  <dc:identifier>101767621</dc:identifier>
  <dc:identifier>http://resource.nlm.nih.gov/101767621</dc:identifier>
  <dc:language>English</dc:language>
  <dc:coverage>United States</dc:coverage>
  <dc:rights>The National Library of Medicine believes this item to be in the public domain. https://creativecommons.org/publicdomain/mark/1.0</dc:rights>
</oai_dc:dc>