The U.S. Food and Drug Administration (FDA) is making efforts to modernize both the 510(k) approval process for medical devices and study designs for drugs and biologics....more
The U.S. Food and Drug Administration (FDA) is continuing its effort to provide industries with updated guidance for digital health technologies. On April 3, 2023, the FDA released draft guidance titled “Marketing Submission...more
Last month, the U.S. Food and Drug Administration (FDA) issued a final guidance on drug and biologic submissions to the agency that include real-world data (RWD) and real-world evidence (RWE). The procedural guidance aims to...more
The U.S. Food and Drug Administration (FDA) re-opened a docket this week seeking scientific data and information about products containing cannabis or cannabis-derived compounds such as cannabidiol (CBD). This move is...more
The U.S. Food and Drug Administration (FDA) released a statement last week describing recent efforts in the agency's evaluation of cannabidiol (CBD). The statement is of particular interest to stakeholders in the cannabis...more