New market exclusivity opportunities emerge for pharmaceutical companies.
In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more
FDA updates its recommendations for distribution of reprints, making requirements more specific and addressing additional types of materials typically distributed....more
Supplements making claims regarding diabetes, genetically customized nutritional benefits, and weight loss are slammed for false advertising.
Recent Federal Trade Commission (FTC) enforcement activities—including a...more
FDA “reminds” manufacturers of the requirements for food and dietary supplement ingredients and finalizes long-awaited liquid dietary supplement guidance.
On January 14, the U.S. Food and Drug Administration (FDA or...more
Proposed requirements dictate a substantial upgrade of the current regulatory standard of care.
On October 29, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule—Current Good Manufacturing...more
Recall notification suggests the agency is ready and willing to use its new, enhanced enforcement authority.
On February 13, the U.S. Food and Drug Administration (FDA) began its first enforcement action under the...more
Affected parties should familiarize themselves with proposed rules for safe food processing and handling and on-farm produce safety; comments to FDA are due by May 16....more