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1. Pediatric HIV infection: drug product development for treatment

2. Delayed graft function in kidney transplantation: developing drugs for prevention

3. Drugs for treatment of partial onset seizures: full extrapolation of efficacy from adults to pediatric patients 2 years of age and older

4. Amyotrophic lateral sclerosis: developing drugs for treatment

5. Smallpox (variola virus) infection: developing drugs for treatment or prevention

6. Considerations for the development of dried plasma products intended for transfusion

7. Slowly progressive, low-prevalence rare diseases with substrate deposition that result from single enzyme defects: providing evidence of effectiveness for replacement or corrective therapies

9. Expansion cohorts: use in first-in-human clinical trials to expedite development of oncology drugs and biologics