21st Century Cures Act: HP&M to Offer Two Complimentary Webinars on Topics of Interest

December 21, 2016

The 21st Century Cures Act was signed into law on December 13, 2016. The Act addresses acceleration of medical product discovery, development, and delivery.  Hyman, Phelps & McNamara, P.C. ("HP&M") will hold complimentary webinars on Thursday, January 12, 2017 from 12:00-1:30 PM (Eastern) and Wednesday, January 18, 2017 from 12:00-1:30 PM (Eastern). The January 12 webinar will focus on the pharmaceutical and biologics provisions, and the January 18 webinar will focus on the device and combination products provisions.

Attendees of the first webinar will hear the significance of provisions such as:

  • Potential use of real world evidence in evaluating new indications for drugs;
  • The extension of priority review voucher programs;
  • Patient-focused drug development; and
  • A new pathway for limited population use of drugs such as antibiotics or antifungals.

Speakers for the first webinar will be Frank Sasinowski, David Clissold, and James Valentine, with Michelle Butler moderating. In 2014, Frank Sasinowski appeared on a panel before the House Energy and Commerce’s Subcommittee on Health to present testimony at the first hearing on the 21st Century Cures Initiative.  See below for a photograph from the hearing.

Attendees of the second webinar will learn about:

  • New issues relating to combination products;
  • Important changes to the regulation of software, including clinical decision support software;
  • Changes to the humanitarian device exemption criteria; and
  • Cleaning and validation requirements for reusable medical devices.

Speakers for the second webinar will be Jeff Shapiro and Allyson Mullen.

Both webinars will provide a question and answer period and attendees will have an opportunity to submit questions during the webinar. Responses to any questions that are not addressed will be available on the HP&M firm website after the webinar.

You can register for the first webinar here and the second webinar here.

Please contact Lisa Harrington at lharrington@hpm.com with any registration questions.