Interventional Treatment of Vascular Anomalies
Vascular anomalies are highly variable in their angioarchitecture, location, and flow dynamics. An individualized, multidisciplinary approach to treatment is required, focusing on improving patient quality of life. With appropriate percutaneous or endovascular treatment, patient satisfaction following interventional therapy is generally high, acknowledging that a complete cure may not always be possible. (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - September 18, 2022 Category: Dermatology Authors: Michael J. Waters, Jonathan Hinshelwood, M. Imran Chaudry Source Type: research
Hemangioma Genetics and Associated Syndromes
This article explores what is known regarding infantile hemangioma (IH) genetics. Despite a great deal of research on this topic, the relationship between IH genetics and pathogenesis has yet to be understood. This article also outlines the appropriate work-up and management of syndromes associated with specific presentations of IH. (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - September 18, 2022 Category: Dermatology Authors: Julie Luu, Colleen H. Cotton Source Type: research
Vascular Anomalies: Current State
The field of vascular anomalies has changed over the last 15 years with a deeper understanding of pathophysiology and genetics leading to improvement in therapies. Clearly, the use of an accepted terminology and nomenclature system has led to improved communication across specialties. Multimodality therapy has thus become the norm through increased multispecialty involvement and cooperation. The validity of various treatments (laser, medical, surgical) is becoming less an issue of controversy, and the timing of each in the natural history of various anomalies is becoming clearer. (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - September 18, 2022 Category: Dermatology Authors: Marcelo Hochman, Lara Wine Lee Tags: Preface Source Type: research
The Food and Drug Administration ’s Role in Dermatologic Drug Development
The mission of the Food and Drug Administration (FDA) is to ensure the safety and effectiveness of dermatologic drugs, as authorized by the Federal Food, Drug, and Cosmetic Act (FD&CA). In this article, we discuss how the FDA ’s policies and practices have continued to evolve to incorporate scientific advances and to facilitate approval for dermatologic drugs in a timely manner for a broad spectrum of patients. We provide several examples to highlight areas where the Division of Dermatology and Dentistry found common g round with stakeholders to increase the therapeutic options for dermatologic patients, while still main...
Source: Dermatologic Clinics - June 22, 2022 Category: Dermatology Authors: Felisa S. Lewis, Kendall A. Marcus Source Type: research
Cutaneous Pharmacokinetic Approaches to Compare Bioavailability and/or Bioequivalence for Topical Drug Products
The evaluation of bioequivalence (BE) involves comparing the test product to its reference product in a study whose fundamental scientific principles allow inferring of the clinical performance of the products. Several test methods have been discussed and developed to evaluate topical bioavailability (BA) and BE. Pharmacokinetics-based approaches characterize the rate and extent to which an active ingredient becomes available at or near its site of action in the skin. Such methodologies are considered to be among the most accurate, sensitive, and reproducible approaches for determining the BA or BE of a product. (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - June 22, 2022 Category: Dermatology Authors: Sam G. Raney, Priyanka Ghosh, Tannaz Ramezanli, Paul A. Lehman, Thomas J. Franz Source Type: research
The History of Dermatology and Dermatologists at the US Food and Drug Administration
In the United States, the Food and Drug Administration ’s (FDA's) regulatory authorities have significantly influenced the products available to treat dermatologic conditions, but at the same time, advances in dermatology have also influenced the FDA’s approach, including the agency’s evaluation of risks and its’ communications to consumers, pat ients, and providers. This essay reviews significant milestones in the history of FDA’s regulation of dermatologic products, with attention paid to significant products, impactful legal changes, and key personnel and organizational changes. (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - June 22, 2022 Category: Dermatology Authors: Vanessa L. Burrows, Markham C. Luke Source Type: research
Food and Drug Administration ’s Role in Dermatology
Prevention and treatment of skin disease are well served by the American Academy of Dermatology Association ’s (AADA) strong partnership with the Food and Drug Administration (FDA). For that reason, I applaud the combined leadership of Markham Luke, MD, PhD from the FDA and AADA Immediate Past President, Bruce Thiers, MD on shaping this issue of Dermatology Clinics, which focuses on the FDA’s relation ship with dermatology. The AADA and the FDA share a wide spectrum of goals when it comes to improving patient care and ensuring public safety in an ever-evolving health care system. (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - June 22, 2022 Category: Dermatology Authors: Bruce A. Brod Tags: Foreword Source Type: research
Food and Drug Administration ’s Role in Dermatology
DERMATOLOGIC CLINICS (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - June 22, 2022 Category: Dermatology Authors: Markham C. Luke Source Type: research
Copyright
ELSEVIER (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - June 22, 2022 Category: Dermatology Source Type: research
Contributors
BRUCE H. THIERS, MD (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - June 22, 2022 Category: Dermatology Source Type: research
Contents
Bruce A. Brod (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - June 22, 2022 Category: Dermatology Source Type: research
Forthcoming Issues
Vascular Anomalies (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - June 22, 2022 Category: Dermatology Source Type: research
The US Food and Drug Administration ’s Intersection with Dermatology
I am writing this opinion piece and one of the forewords to this issue from the confines of my alternate workplace (my home) in the midst of the COVID-19 pandemic. My Food and Drug Administration (FDA) work allows me to do much of it from home currently due to twenty-first-century technology (ie, the Internet, thumb-sized desk-top video cameras, and collaborative work software). My coworkers and my Division have maintained a high level of work throughout and have met our work deadlines despite the pandemic. (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - June 3, 2022 Category: Dermatology Authors: Markham C. Luke Tags: Preface Source Type: research
Postmarket Assessment for Drugs and Biologics Used in Dermatology and Cutaneous Adverse Drug Reactions
Postmarket surveillance is critical for the identification of rare safety risks, which are unlikely to be identified during clinical trials and the drug development program. Rare adverse drug reactions with the potential for serious outcomes, including fatalities, include the severe cutaneous adverse reactions of Stevens –Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms. Dermatologists play an important role in the diagnosis of these serious drug reactions and contribute to drug safety by reporting cases of suspected cutaneous adverse drug reactions. (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - June 2, 2022 Category: Dermatology Authors: Melissa Reyes, Cindy Kortepeter, Monica Mu ñoz Source Type: research
Regulation of Cosmetics in the United States
This article describes the statutes and regulations relevant to cosmetic regulation by the Food and Drug Administration (FDA). It also describes relevant domestic programs of the FDA (Voluntary Cosmetic Registration Program, Good Manufacturing Practice guidance, Adverse Event Reporting System, Recalls) and international efforts regarding cosmetics regulation. (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - June 2, 2022 Category: Dermatology Authors: Linda M. Katz, Kathleen M. Lewis, Susan Spence, Nakissa Sadrieh Source Type: research