In this issue, guest editors bring their considerable expertise to this important topic.
1. Cover image - p. i 2. Title page - p. i 3. Table of Contents - p. i 4. Copyright - p. ii 5. Contributors - p. iii 6. Forthcoming Issues - p. viii 7. Foreword - p. ix 8. Preface - p. xi 9. The History of Dermatology and Dermatologists at the US Food and Drug Administration - p. 237 10. The Food and Drug Administration’s Role in Dermatologic Drug Development - p. 249 11. Postmarket Assessment for Drugs and Biologics Used in Dermatology and Cutaneous Adverse Drug Reactions - p. 265 12. How Does the Food and Drug Administration Approve Topical Generic Drugs Applied to the Skin? - p. 279 13. Dermatology Drugs for Children—U.S. Food and Drug Administration Perspective - p. 289 14. Regulation of Medical Devices for Dermatology - p. 297 15. Regulation of Cosmetics in the United States - p. 307 16. Cutaneous Pharmacokinetic Approaches to Compare Bioavailability and/or Bioequivalence for Topical Drug Products - p. 319 17. Measuring What Matters to Patients in Dermatology Drug Development: A Regulatory Perspective - p. 333
In this issue, guest editors bring their considerable expertise to this important topic.
1. Cover image - p. i 2. Title page - p. i 3. Table of Contents - p. i 4. Copyright - p. ii 5. Contributors - p. iii 6. Forthcoming Issues - p. viii 7. Foreword - p. ix 8. Preface - p. xi 9. The History of Dermatology and Dermatologists at the US Food and Drug Administration - p. 237 10. The Food and Drug Administration’s Role in Dermatologic Drug Development - p. 249 11. Postmarket Assessment for Drugs and Biologics Used in Dermatology and Cutaneous Adverse Drug Reactions - p. 265 12. How Does the Food and Drug Administration Approve Topical Generic Drugs Applied to the Skin? - p. 279 13. Dermatology Drugs for Children—U.S. Food and Drug Administration Perspective - p. 289 14. Regulation of Medical Devices for Dermatology - p. 297 15. Regulation of Cosmetics in the United States - p. 307 16. Cutaneous Pharmacokinetic Approaches to Compare Bioavailability and/or Bioequivalence for Topical Drug Products - p. 319 17. Measuring What Matters to Patients in Dermatology Drug Development: A Regulatory Perspective - p. 333