
<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>COVID-19 public health emergency : general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators</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>Biological Products</dc:subject>
  <dc:subject>COVID-19 Drug Treatment</dc:subject>
  <dc:subject>Drug Approval</dc:subject>
  <dc:subject>Drug Industry</dc:subject>
  <dc:subject>Drugs, Investigational</dc:subject>
  <dc:subject>Drug Evaluation, Preclinical</dc:subject>
  <dc:subject>Investigational New Drug Application</dc:subject>
  <dc:description>FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide general considerations to assist sponsors in preparing pre-investigational new drug application (pre- IND) meeting requests for COVID-19 related drugs1 for the duration of the COVID-19 public health emergency. As described in further detail in this guidance, FDA recommends that sponsors initiate all drug development interactions for COVID-19 related drugs through IND meeting requests. This guidance is intended to provide sponsors with an initial framework to help organize their preIND meeting requests during the COVID-19 public health emergency. This document is intended to complement other guidance documents providing recommendations regarding drug development programs for COVID-19, including the guidance for industry COVID-19: Developing Drugs and Biological Products for Treatment or Prevention (May 2020).</dc:description>
  <dc:publisher>[Silver Spring, MD] : Center for Drug Evaluation and Research, May 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 Drug Evaluation and Research (U.S.), issuing body.</dc:contributor>
  <dc:contributor>Center for Biologics 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 (10 pages)).</dc:format>
  <dc:identifier>nlm:nlmuid-9918231202606676-pdf</dc:identifier>
  <dc:identifier>9918231202606676</dc:identifier>
  <dc:identifier>http://resource.nlm.nih.gov/9918231202606676</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>