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Titles
- ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin1
- Chemistry, manufacturing, and controls changes to an approved application: certain biological products1
- Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards1
- Development of abbreviated new drug applications during the COVID-19 pandemic: questions and answers1
- FDA oversight1
- Field alert report submission: questions and answers1
- Protecting participants in bioequivalence studies for abbreviated new drug applications during the COVID-19 public health emergency1
- Providing regulatory submissions in alternate electronic format1
- Providing regulatory submissions in electronic format: standardized study data1