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33. Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff

34. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment

35. Chronic obstructive pulmonary disease: use of the St. George's Respiratory Questionnaire as a PRO assessment tool

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

38. Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff