Janice Hogan

Janice Hogan is the managing partner of Hogan Lovells' Philadelphia office and is co-director of its FDA/Medical Device practice. Janice focuses her practice primarily on the representation of medical device, pharmaceutical, and biological product manufacturers before the U.S. Food and Drug Administration (FDA).

A biomedical engineer, she held positions in marketing/marketing research for a major pharmaceutical manufacturer prior to becoming an attorney. She has authored articles regarding the medical device 510(k) review process, regulation of medical software, orphan drug regulation, and medical device products liability, and a chapter of a recent textbook, Promotion of Biomedical Products (FDLI 2006).

Janice has served as an adjunct professor at the University of the Sciences in Philadelphia and as a guest lecturer at the Wharton School, Drexel University, and Stanford University on the development and regulation of medical products. She is also a frequent lecturer at FDA regulatory law symposia and conferences on topics related to premarket approval of medical products, combination products regulation, and product development, and has served on the faculty of FDA's staff college training for new review staff.

Questions to the author may be directed to Janice.hogan@hoganlovells.com.

ARTICLES BY JANICE HOGAN

  • Optimizing FDA Submissions For Companion Diagnostics
    6/13/2016

    In this article — part one of a two-part series — we will examine the history of companion diagnostic approvals by FDA. Through this process, trends can be identified to suggest better approaches to optimize review times.
  • Does the Humanitarian Device Exemption Process Work (And Is It Worth Pursuing)?
    2/25/2016

    Although Congress has made multiple changes to the law to improve the HDE process, including allowances for profit to be made in certain cases, use of the process remains limited. Additionally, there is evidence that increasing review times may be creating new barriers to use of the process. Clarification of the circumstances in which HDEs can be priced to generate a profit, as well as greater clarity on the circumstances in which HDE products can progress to broader approvals, will go a long way toward improving this process' viability.  
  • Are The Special And Abbreviated 510(k) Clearance Mechanisms Still Viable?
    12/8/2015

    In 1998, FDA issued The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance, which offered two alternative mechanisms to a traditional 510(k) notice, each designed to reduce regulatory burden and, consequently, review time. But, 17 years later, do the special and abbreviated 510(k) mechanisms still offer those advantages?
  • The De Novo Classification Process: A Work in Progress
    9/8/2015

    Launched in 1997, the de novo process was used infrequently in its first 15 years. In 2012, Congress reformed the process as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). But have those reforms improved review times or eased the clinical data burden? Have they opened the de novo pathway to more products, or facilitated competitors’ entry into the marketplace via 510(k)? Here, we answer those questions and more. 
  • How Will Conducting A Medical Device Clinical Trial Outside The U.S. Impact Your FDA Approval?
    6/8/2015

    The rapidly increasing cost of clinical research has led to growing interest in cost-saving strategies.  A 2012 report by Kramer and Schulman indicated that the cost of clinical research has exceeded inflation by 7.4 percent annually for the last 20 years. Given this trajectory, manufacturers of medical products have pursued a number of options to reduce cost, including the use of data from sites outside the United States.
More Articles by Janice Hogan