Latest Publications


FDA and DoD Launch Priority Development Program for Medical Products Essential for the Urgent Care of U.S. Military Personnel

On January 16, 2018, the U.S. Food and Drug Administration (FDA) and the Department of Defense’s (DoD) Office of Health Affairs (“Health Affairs”) launched a joint program to help expedite the development and availability of...more

K&L Gates Triage: FDA & Health Care Update: The Use of Real-World Data and Real-World Evidence in Medical Product Development

In this episode, Erica Jackson discusses recent guidance from the Food & Drug Administration (FDA) on the consideration of real-world data and real-world evidence in regulatory decision-making related to medical devices and...more

Recent FDA Steps to Advance Medical Device Access and Innovation

On November 6, 2017, U.S. Food and Drug Administration (“FDA” or “the Agency”) Commissioner Dr. Scott Gottlieb reiterated the Agency’s commitment to advancing medical device access and innovation by stating, “[o]ur goal is to...more

11/13/2017  /  510(k) RTA , FDA , Innovation , Medical Devices

FDA Announces Public Meetings and Requests Comments on Agricultural Biotechnology Education and Outreach Initiative

On October 13, 2017, the U.S. Food and Drug Administration (the “FDA”) announced in the Federal Register a notice of two upcoming public meetings and request for comments related to the initial phase of the Agency’s...more

FDA Seeks Stakeholder Input on Regulatory Reform Efforts

On September 8, 2017, the Food and Drug Administration (“FDA”) became the latest in a line of federal departments and agencies to seek public input on approaches to modify regulations and reduce the burden on stakeholders....more

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