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

nlm:nlmuid-101734398-pdf

5. I.G. Farbenindustrie A.G., Abteilung: Behring Werke, Marburg a.d. Lahn, Germany

nlm:nlmuid-101708937-bk

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

nlm:nlmuid-101760024-pdf

7. Considerations in demonstrating interchangeability with a reference product

nlm:nlmuid-101760108-pdf

8. Osteoporosis: nonclinical evaluation of drugs intended for treatment

nlm:nlmuid-101760325-pdf

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

nlm:nlmuid-101760343-pdf

10. Adaptive designs for clinical trials of drugs and biologics

nlm:nlmuid-101760568-pdf