Food and Drug Administration’s Role in Dermatology, An Issue of Dermatologic Clinics

1st Edition, Volume 40-3 - June 24, 2022
Editor: Markham C. Luke
Language: English
Hardback ISBN:
9 7 8 - 0 - 3 2 3 - 8 4 9 6 9 - 2
eBook ISBN:
9 7 8 - 0 - 3 2 3 - 8 4 9 7 0 - 8

In this issue, guest editors bring their considerable expertise to this important… Read more

Food and Drug Administration’s Role in Dermatology, An Issue of Dermatologic Clinics

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In this issue, guest editors bring their considerable expertise to this important topic.

Cover image
Title page
Table of Contents
Copyright
Contributors
Forthcoming Issues
Foreword
Preface
The History of Dermatology and Dermatologists at the US Food and Drug Administration
Key points
Introduction
Origins of the federal regulation of dermatologic products
Dermatology makes landfall at THE U.S. Food and Drug Administration
Evaluating and communicating risks associated with dermatologic products
Regulatory challenges and therapeutic innovations in the 21st century
Clinics care points
The Food and Drug Administration’s Role in Dermatologic Drug Development
Key points
Introduction
The regulatory framework
Special topics of dermatologic concern
Summary
Supplementary data
Postmarket Assessment for Drugs and Biologics Used in Dermatology and Cutaneous Adverse Drug Reactions
Key points
Introduction
Definitions
Discussion
Summary
Clinics care points
Disclosure
How Does the Food and Drug Administration Approve Topical Generic Drugs Applied to the Skin?
Key points
Introduction
History of topical drug regulations in the United States
Commonly used topical dermatologic dosage forms
Approaches for establishing therapeutic equivalence of generic topical dermatologic drug products
Summary
Clinics care points
Disclosure statement
Dermatology Drugs for Children—U.S. Food and Drug Administration Perspective
Key points
Introduction
Early regulatory history: a “free-for-all”
The Orphan Drug Act
Pediatric rules
International consensus
The carrot
The stick
Continued evolution of regulations—more carrots
Permanent regulations
The Food and Drug Administration today
Establishing effectiveness
Modeling and extrapolation
Pharmacokinetic considerations
Public–private partnership
Benefits from legislation
Discussion
Disclosure
Clinics care points
Regulation of Medical Devices for Dermatology
Key points
Introduction
History
Definitions
Devices in dermatology
Additional sources of information
Disclosure
Regulation of Cosmetics in the United States
Key points
Introduction
Laws and regulations
Domestic activities
International activities
Summary
Clinics care points
Disclosure
Cutaneous Pharmacokinetic Approaches to Compare Bioavailability and/or Bioequivalence for Topical Drug Products
Key points
Introduction
In vitro cutaneous pharmacokinetics
In vivo cutaneous (epidermal) pharmacokinetics
In vivo cutaneous (dermal) pharmacokinetics
Summary
Clinics care points
Measuring What Matters to Patients in Dermatology Drug Development: A Regulatory Perspective
Key points
Introduction
Current landscape of dermatologic clinical trials
Regulatory review of clinical outcome assessments
Challenges and opportunities in capturing the patient voice in dermatologic clinical trials
Summary
Disclaimer statement

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Food and Drug Administration’s Role in Dermatology, An Issue of Dermatologic Clinics

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Markham C. Luke