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Titles
- Amyotrophic lateral sclerosis: developing drugs for treatment1
- Considerations for the development of dried plasma products intended for transfusion1
- Delayed graft function in kidney transplantation: developing drugs for prevention1
- Drugs for treatment of partial onset seizures: full extrapolation of efficacy from adults to pediatric patients 2 years of age and older1
- Expansion cohorts: use in first-in-human clinical trials to expedite development of oncology drugs and biologics1
- Pediatric HIV infection: drug product development for treatment1
- Qualification process for drug development tools: guidance for industry and FDA staff1
- Slowly progressive, low-prevalence rare diseases with substrate deposition that result from single enzyme defects: providing evidence of effectiveness for replacement or corrective therapies1
- Smallpox (variola virus) infection: developing drugs for treatment or prevention1