Today, FDA published a notice in the Federal Register announcing a public workshop on July 11-12 entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.” This workshop builds on FDA’s ongoing efforts to implement the Real-World Evidence (RWE) Framework published in December 2018, which we previously discussed in this post. According to … Continue Reading
On December 7, FDA published the much-anticipated “Framework for FDA’s Real-World Evidence Program” for drugs and biological products (the “Framework”). In a statement announcing the Framework, Commissioner Gottlieb recognized the opportunities and challenges of using real-world data (“RWD”) and real-world evidence (“RWE”) to enhance regulatory decision-making and noted that leveraging this information is “a top … Continue Reading
There are two papers in the May 15 volume of the Annals of Internal Medicine that discuss digital health applications and are illustrative of the topics being considered by physicians as they evaluate the adoption and impact of digital solutions. These papers serve as examples of the active dialogue taking place around the appropriate regulatory … Continue Reading
On February 1, 2018, Covington’s Digital Health team hosted a webinar examining U.S. and EU regulatory issues for digital health associated with pharmaceuticals. Here are some key takeaways from that webinar: Neela Paykel from Proteus Digital Health, noted that “you need to think outside the box for how to engage, whether you’re a pharma company … Continue Reading
On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act” (the “Software Policies Draft Guidance”). These draft guidances announce the … Continue Reading
On November 14, lawyers from Teva Pharmaceuticals and Covington & Burling discussed digital health innovation from a medical device regulation perspective in the U.S. and the EU. The presentation by Rachel Turow, Executive Counsel – Regulatory Law, Teva Pharmaceuticals, and Grant Castle, Scott Danzis, Sarah Cowlishaw, and Christina Kuhn of Covington, covered topics such as … Continue Reading
On Friday, July 28, FDA announced a new Software Pre-certification (Pre-Cert) Pilot Program in a Federal Register notice. The Pre-Cert program is one of three main action items discussed in the agency’s recently-released Digital Health Innovation Action Plan. CDRH also held a webinar on August 1 to provide an overview of the program and answer … Continue Reading
On April 5, the Federal Trade Commission (FTC), in conjunction with the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS), released a new web-based interactive tool to assist mobile health app developers in navigating applicable federal laws and regulations in the areas of advertising and marketing, medical devices, and … Continue Reading
