Earlier this month, the FDA released programmatic guidance intended to clarify the current review practices for the Humanitarian Device Exemption (“HDE”) Program (“Guidance”) reflecting recent changes in the HDE Program resulting from statutory amendments made by the 21st Century Cures. The Guidance addresses frequently asked questions about FDA actions on HDE applications, post-approval requirements,

On April 30, 2019, Assistant Attorney General Brian Benczkowski announced that the Department of Justice (“DOJ”) had published an updated version of the Criminal Division’s 2017 guidance publication “Evaluation of Corporate Compliance Programs.”  In making the announcement, Assistant Attorney General Benczkowski said the update was designed to “better harmonize the prior Fraud Section publication with

Epstein Becker Green Health Care and Life Sciences Client AlertOn July 15, 2014, the U.S. Food and Drug Administration (“FDA”) released draft guidance that provides extensive commentary on FDA’s current thinking regarding the clinical trial informed consent process. Once finalized, this document, entitled “Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors” (“Draft Guidance”), will replace FDA’s 1998 informed consent