CPG Sec. 446.100 Regulatory Action Regarding Approved New Drugs and Antibiotic Drug Products Subjected to Additional Processing or other Manipulations
Detailed guidance document from FDA and regulatory agencies.
Document Details
Compliance Policy Guide (CPG)
January 18, 1991
Center for Drug Evaluation and Research
835ffe14-080b-42e1-91af-560a4c342b5c
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