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  • Expert Workshop: Strengthening Risk Evaluation and Mitigation Strategies (REMS) Through Systematic Analysis, Standardized Design, and Evidence-Based Assessment

    September 25, 2013

  • Antibiotic Development and Market Failure: No Quick Fix

    September 20, 2013, Gregory W. Daniel

  • An Overview of the Design and Implementation of FDA’s Prospective Routine Observational Monitoring Program Tools for Safety Surveillance

    September 16, 2013

    • Audio
  • Unmet Patient Needs as the Focus of a New Regulatory Pathway

    August 13, 2013, Gregory W. Daniel

  • Special Medical Use: Limited Use for Drugs Developed in an Expedited Manner to Meet an Unmet Medical Need

    August 1, 2013

  • Findings from a Mini-Sentinel Assessment: Rotavirus Vaccines and Risk of Intussusception

    July 23, 2013

    • Audio
  • Reducing the Threat of Counterfeit and Unapproved Drugs in Clinical Settings

    July 19, 2013

  • State of Biomedical Innovation Conference

    July 16, 2013

  • Can Smartphones Help Improve Access To Medications?

    June 7, 2013, Gregory W. Daniel

  • Innovative Technologies and Nonprescription Medications: Addressing Undertreated Diseases and Conditions through Technology Enabled Self-Care

    May 9, 2013

  • Promoting the Effective Use of a Common Data Model

    May 8, 2013

  • Coverage With Evidence Development for Medicare Beneficiaries

    May 2013, Gregory W. Daniel, Erin K. Rubens and Mark B. McClellan

  • Accessing and Communicating Device Information: UDI as a Tool for Improved Patient and Provider Connectivity

    March 18, 2013

  • Highlights from the Fifth Annual Sentinel Initiative Public Workshop

    March 7, 2013

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  • Improved Access to Device Information:What a UDI System Can Do for Patients and Consumers

    February 26, 2013

    • Audio
  • The State of Drug Safety Surveillance in the U.S.: Much Improved, More to Come

    February 8, 2013, Gregory W. Daniel

    • Video
  • Sentinel Initiative Public Workshop

    January 31, 2013

  • Amphetamines, Atomoxetine and the Risk of Serious Cardiovascular Events in Adults

    January 2013, Hedi Schelleman, Warren B. Bilker, Stephen E. Kimmel, Gregory W. Daniel, Craig Newcomb, James P. Guevara, Mark J. Cziraky, Brian L. Strom and Sean Hennessy

  • UDI Expert Workshop #2: Identifying Steps for Implementation and Integration of UDI within Electronic Data Infrastructure of Care Delivery Sites

    December 13, 2012

  • Developing a Taxonomy of Surveillance Methods for Medical Product Safety

    December 7, 2012

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  • Biomedical Innovation in a Challenging Fiscal Environment

    November 30, 2012, Gregory W. Daniel

  • The Value of Unique Device Identification (UDI) for Health Care Systems and Providers

    November 5, 2012

    • Audio
  • Brookings Roundtable on Active Medical Product Surveillance: Findings from a Mini-Sentinel Medical Product Assessment

    October 16, 2012

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  • UDI Expert Workshop #1: Exploring the Opportunities and Challenges Associated with Capturing UDIs in Claims

    October 15, 2012

  • Unique Device Identification (UDI) Implementation Work Group Kick-Off

    July 16, 2012

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