• Feature ArticlesFeature Articles

    Preparing for Market: Reimbursement Strategies for Cell and Gene Therapies

    • 08 September 2017
    In this interview with Regulatory Focus , Ted Slocomb and Michael Werner, two leaders from the Alliance for Regenerative Medicine (ARM), provide insight into future challenges and opportunities for ensuring market access and value-based reimbursement for gene and cell therapies. Cell and gene therapies represent a new, transformative era in medicine. For many indications, these products offer the promise of durable - even potentially curative – treatments and in many c...
  • Regulatory NewsRegulatory News

    Congressional Hearings Focus on Compassionate Use, FDA Issues

    Aside from Thursday’s summit on President Barack Obama’s Precision Medicine Initiative (which can be viewed in its entirety  here ), the Senate and House held two other hearings focused on the inner workings of the US Food and Drug Administration (FDA). At the Senate Homeland Security and Government Affairs Committee hearing, senators discussed FDA’s compassionate use program with the Goldwater Institute’s Dary Olsen, who’s been behind all of the Right-to-Try state legi...
  • Regulatory NewsRegulatory News

    Cruz Calls for Major Overhaul of FDA

    Republican presidential candidate Sen. Ted Cruz (TX) and Sen. Mike Lee (R-Utah) on Friday introduced a bill that would completely overhaul the way the US Food and Drug Administration (FDA) operates. More specifically, the “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act (S. 2388), or the RESULT Act,” would: allow for reciprocal approval of drugs, devices and biologics from foreign sponsors in EU member countries, Israel, Australia, Canada and Japan r...