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- CMC postapproval manufacturing changes for specified biological products to be documented in annual reports2
- Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards2
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- Technical specifications for submitting clinical trial data sets for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH)2
- ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin1
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