Eva Schifini

Aug 7, 2024 | lexology.com | Randy Prebula |Jason Conaty |Eva Schifini |Ashley Grey

The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance to align it with current user fee program expectations.

Feb 21, 2024 | lexology.com | Robert Church |Heidi Forster Gertner |Blake Wilson |Stephanie Agu |Eva Schifini

Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in Clinical Trials.” In the Federal Register notice announcing the draft guidance, FDA explained that there has been “an increase in the use of DMCs in many disease areas not involving serious morbidity or mortality.” Among other things, FDA noted that DMCs can provide specialized expertise to evaluate...

Jan 31, 2023 | jdsupra.com | Sally Gu |Lynn Mehler |Eva Schifini

In an official statement last week, the U.S. Food and Drug Administration (FDA) announced its conclusion that the existing regulatory framework for foods and dietary supplements is not appropriate for the regulation of certain products containing cannabidiol (CBD). In the same statement, FDA invited Congress to create a new regulatory pathway for such CBD products.

Jan 31, 2023 | lexology.com | Lynn Mehler |Sally Gu |Eva Schifini

In an official statement last week, the U.S. Food and Drug Administration (FDA) announced its conclusion that the existing regulatory framework for foods and dietary supplements is not appropriate for the regulation of certain products containing cannabidiol (CBD). In the same statement, FDA invited Congress to create a new regulatory pathway for such CBD products.