FDA issued final guidance to provide clarity on the definition of “remanufacturing” for reusable devices needing maintenance or repair. The guidance seeks to ensure consistency while promoting understanding of federal law and regulations implicated by remanufacturing activities.

The U.S. Environmental Protection Agency, the U.S. Food and Drug Administration, and the U.S. Department of Agriculture have developed a plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology.

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Today, the FDA took important steps to advance the FDA’s regulatory process for intentional genomic alterations (IGAs) in animals.

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.