Articles by Janice Hogan

1. Optimizing FDA Submissions For Companion Diagnostics: Alternative Evaluation Pathways To Streamline Approval 6/17/2016

   In part one of this series, we examined the history of companion diagnostic approvals by FDA and identified trends to suggest better approaches to optimize the review process. Here, we will analyze new avenues sponsors may consider to further streamline the review of these important products through the assessment of various regulatory submission types and FDA guidance.

2. 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.

3. 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.  

4. 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?

5. 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. 

6. 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.