Judy O’Grady, a partner with Pepper Hamilton and a member of the firm’s Health Sciences Department, will be speaking at the Food and Drug Law Institute's (FDLI's) Annual Conference 2018 taking place in Washington, D.C. on May 3-4, 2018. Ms. O'Grady will be speaking on the following breakout session on Friday, May 4 at 11:30–12:20 PM:
Evolving Regulatory Pathways for Medical Devices
In recent years, the FDA has finalized several medical device guidance documents that could dramatically impact the regulatory pathways available to medical device manufacturers. Are manufacturers effectively taking advantage of these new options, for example, by leveraging non-traditional data sources, like real world evidence or patient preference information, for regulatory purposes? Are the new options making the regulatory process more efficient for manufacturers and FDA? Has FDA’s decision-making process been impacted by the new options?
Judy O’Grady, Partner, Pepper Hamilton LLP
Jonette Foy, Associate Director for Policy, CDRH, FDA
Rachel Turow, Executive Counsel – Regulatory Law, TEVA Pharmaceuticals, Inc.
Cassie Scherer, Principal Legal Counsel, Corporate Legal Regulatory, Medtronic
Ronald Reagan Building and International Trade Center
1300 Pennsylvania Avenue NW
Washington, D.C. 20004