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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
- Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases1
- Competitive generic therapies1
- Considerations for the development of dried plasma products intended for transfusion1
- Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff1