The ball has dropped on the healthcare and life sciences industry’s unique New Year tradition, the J.P. Morgan Healthcare Conference, so all eyes turn to 2024. To help define a path forward, Morgan Lewis FDA and healthcare partners assembled an in-depth report on drug and biologic developments at the FDA.
As Prescribed
YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
FDA’s Center for Biologics Evaluation and Research (CBER), the locus of regulating cell and gene therapies among other expanding areas of biotech, is poised for change on a number of important fronts—leadership, significant growth, and plans to address challenging scientific and regulatory issues. With a well-earned reputation of stability, and slow, plodding progress, moments with so many elements in flux at FDA don’t come around often, so it is worth keeping an eye on how these begin to unfold to have a sense of where CBER—central to many of the exciting developments in industry—is headed.
FDA recently published a Federal Register notice announcing a public listening session on good manufacturing practices (GMPs) for cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which added Section 606 of the Federal Food, Drug, and Cosmetic Act requiring FDA to establish GMP regulations for cosmetics.