
<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>How to prepare a pre-request for designation (pre-RFD)</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>Equipment and Supplies -- classification</dc:subject>
  <dc:subject>Drugs, Investigational -- classification</dc:subject>
  <dc:subject>Investigational New Drug Application</dc:subject>
  <dc:publisher>[Silver Spring, Maryland] : Office of Combination Products, Office of the Commissioner, February 2018</dc:publisher>
  <dc:contributor>United States. Department of Health and Human Services, issuing body.</dc:contributor>
  <dc:contributor>United States. Food and Drug Administration. Office of the Commissioner. Office of Medical Programs and Tobacco. Office of Combination Products, issuing body.</dc:contributor>
  <dc:type>Guideline</dc:type>
  <dc:type>Technical Report</dc:type>
  <dc:format>Text</dc:format>
  <dc:format>Illustrations</dc:format>
  <dc:format>1 online resource (1 PDF file (15 pages))</dc:format>
  <dc:identifier>nlm:nlmuid-101734055-pdf</dc:identifier>
  <dc:identifier>101734055</dc:identifier>
  <dc:identifier>http://resource.nlm.nih.gov/101734055</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>