Preview Mode Links will not work in preview mode

Triage: Rapid Legal Lessons for Busy Health Care Professionals is a podcast created by the K&L Gates health care practice group to inform our clients and friends of the firm about the latest developments in health law. If you would like to provide feedback or would like to suggest a topic for a future episode of Triage, please contact usUse the icons below to subscribe to Triage via your favorite podcast app to have our episodes delivered directly to you as they become available.

Nov 12, 2020

In this week’s episode, Kenneth Kennedy discusses FDA’s ongoing focus on the issuance of warning letters to firms marketing fraudulent COVID-19 products, and to manufacturers who have failed to meet certain requirements under applicable FDA Emergency Use Authorizations (EUAs), as well as what manufacturers and...


Aug 27, 2020

FDA’s recent release of new guidance on civil money penalties for the failure to submit required information to the ClinicalTrials.gov data bank may indicate a renewed interest in the enforcement of these requirements. On this week’s episode, Lindsey Rogers-Seitz and Kenneth Kennedy discuss the scope of...


Mar 26, 2020

In this week’s episode, Kenneth Kennedy discusses several of FDA’s strategies for helping stakeholders in the drug and medical device industry support health care providers in their fight against the COVID-19 outbreak. In particular, Mr. Kennedy discusses several unprecedented measures FDA has taken with respect...


Aug 9, 2018

The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents related to its requirement for shared risk evaluation and mitigation strategies (REMS) and the process for requesting a waiver of this requirement. In this episode, Michael Hinckle summarizes current requirements for single...


Dec 15, 2017

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 their development. The episode notes stakeholders should work closely with the FDA so that...