• Regulatory NewsRegulatory News

    FDA Hires World-Renowned Cardiologist to Oversee Medical and Regulatory Policy

    One of the world's top cardiologists is set to join the US Food and Drug Administration (FDA) next month to oversee four of its largest regulatory divisions, FDA Commissioner Margaret Hamburg has announced. In a 26 January 2014 announcement, Hamburg said FDA had appointed Robert Califf as deputy commissioner for Medical Products and Tobacco. Califf is a familiar figure to many within the life sciences field. He is currently the director of the Duke Translational Medici...
  • Citing Public Health Needs, FDA Alters Labeling Standards for Smoking Cessation Products

    The US Food and Drug Administration (FDA) has, in response to three citizen petitions submitted to the agency, agreed to modify the labeling of nicotine replacement therapies (NRT) to indicate that consumers are allowed to use other NRTs and infrequently smoke when attempting to quit smoking using an NRT. Background Nicotine replacement products have been on the US market for nearly three decades, and are commonly used to wean users of tobacco products off the substance...
  • Court Upholds FDA Labeling Regulations on Cigarette Packaging

    The Cincinnati Court of Appeals has upheld the US Food and Drug Administration's (FDA) authority to require cigarette companies to adorn their tobacco products with graphic labeling, ruling FDA's advertising regulations do not violate the companies' rights to free speech. "There can be no doubt that the government has a significant interest in preventing juvenile smoking and in warning the general public about the harms associated with the use of tobacco products," wrote...