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- Address Presented at the Festschrift to Honor Dr. Philip L. Calcagno, Washington, DC1
- Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters1
- Assessing the effects of food on drugs in INDs and NDAs: clinical pharmacology considerations1
- Benefit-risk assessment for new drug and biological products: guidance for industry1
- 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
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