The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA Guidance for Industry: Self-Identification of Generic Drug Facilities, Sites, and Organizations
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM316672.pdf
Content:
This guidance is intended to assist human generic drug facilities, sites, and organizations by describing how the FDA will implement an identification requirement contained in the Generic Drug User Fee Amendments of 2012
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