http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM153222.pdf
Guidance for Industry
Formal Meetings Between the FDA and Sponsors or Applicants
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
May 2009
Procedural
Revision 1
月曜日, 6月 08, 0021
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