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4. Pediatric information incorporated into human prescription drug and biological product labeling

5. Considerations in demonstrating interchangeability with a reference product

6. Osteoporosis: nonclinical evaluation of drugs intended for treatment

7. Placebos and blinding in randomized controlled cancer clinical trials for drug and biological products

8. Adaptive designs for clinical trials of drugs and biologics

9. Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases