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: PET Drugs - Current Good Manufacturing Practice (CGMP)
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070306.pdf
Content:
This guidance is intended to help positron emission tomography (PET) drug producers better understand FDA’s thinking concerning compliance with the current good manufacturing practice (CGMP) regulations.
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
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