• Hamburg: Smart Regulation Supports Public Health and Innovation, FDA Creating Business Liaison

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg delivered a speech at the Commonwealth Club of San Francisco on 6 February in which she discussed FDA's dual role in protecting health and getting innovative products to market. "As FDA commissioner, I have been surprised by how many people ask whether I favor safety or innovation," said Hamburg. "I favor both." "Protecting the public health-while encouraging, not discouraging innovation must be the ...
  • CDRH Releases 2012 Strategic Priorities, Looks to Boost Innovation With New Regulatory Pathway and Regulatory Science

    The US Food and Drug Administrations (FDA) Center for Devices and Radiological Health (CDRH) released their strategic priorities for the coming year on 24 January 2012.  The priorities consist of four main strategies and corresponding implementation goals, and includes several new and important initiatives. CDRH's first strategy is to "fully implement a total product life cycle approach to product regulation that takes "into consideration all of the relevant infor...
  • ULTRA Bill Introduced in the House Legislation Seeks to Permit Broader Use of Scientific Data to Support Surrogate Endpoints for 'Ultra Orphan' Drug Approvals

    • 03 January 2012
    Two congressmen have introduced legislation that would amend the Food, Drug and Cosmetic Act to provide an easier, accelerated approval pathway for drugs for "Ultra Orphan" diseases, which affect fewer than 6,000 people.  In comparison, "Orphan Diseases" affect fewer than 200,000 individuals. The bill, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA) (H.R. 3737), would allow for surrogate endpoints that is "reasonably likely, based on epidemiologic,...