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Titles
- Population pharmacokinetics1
- Pre-Launch Activities Importation Requests (PLAIR)1
- Principles of premarket pathways for combination products: guidance for industry and FDA Staff1
- 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 and non-electronic format: promotional labeling and advertising materials for human prescription drugs1
- Providing regulatory submissions in electronic format: certain human pharmaceutical product applications and related submissions using the eCTD specifications1
- Providing regulatory submissions in electronic format: content of the risk evaluation and mitigation strategies document using structured product labeling1
- Providing regulatory submissions in electronic format: standardized study data1
- Providing submissions in electronic format: postmarketing safety reports1