PET Drug Applications - Content and Format for NDAs and ANDAs: Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
September 1, 2011
May 15, 2020
a4320966-98dd-464c-8b5e-d455c45c3f0e
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