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Titles
- COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators1
- General principles for evaluating the abuse deterrence of generic solid oral opioid drug products1
- Human gene therapy for hemophilia1
- Human gene therapy for rare diseases1
- Human gene therapy for retinal disorders1
- Long term follow-up after administration of human gene therapy products1
- Microdose radiopharmaceutical diagnostic drugs: nonclinical study recommendations1
- Nonclinical considerations for mitigating nonhuman primate supply constraints arising from the COVID-19 pandemic1
- Nonclinical evaluation of the immunotoxic potential of pharmaceuticals: guidance for industry1
- Physiologically based pharmacokinetic analyses--format and content1
- Recurrent herpes labialis: developing drugs for treatment and prevention1
- S1B(R1) addendum to S1B testing for carcinogenicity of pharmaceuticals: guidance for industry1
- S9 nonclinical evaluation for anticancer pharmaceuticals: questions and answers1
- Smallpox (variola virus) infection: developing drugs for treatment or prevention1