• 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

    Senate Bill Seeks to Create Standards Body for Regenerative Medicine

    Sen. Tammy Baldwin (D-WI) introduced a bill on Tuesday to promote the development of regulatory science and standards for regenerative medicine and advanced therapies. The bill, known as the Advancing Standards in Regenerative Medicine Act , would require the US Food and Drug Administration (FDA) to oversee the creation of a "Standards Coordinating Body" for regenerative medicine. Regenerative medicine and advanced therapies belong to a growing field of medicine that i...
  • Regulatory NewsRegulatory News

    New Bill Would Reduce FDA Burden on Research-Use Devices

    A new bill introduced in the House of Representatives by a prominent Republican legislator would make it easier for companies to distribute investigational medical devices explicitly labeled as being "for research use only (RUO)." The Medical Testing Availability Act of 2015 , sponsored by Rep. Michael Burgess (R-TX), the vice chairman of the Energy and Commerce Committee's Subcommittee on Health, is similar to an identically titled bill introduced by Burgess in 2013 ....
  • Regulatory NewsRegulatory News

    FDA Announces Hire of New Top Food and Dietary Supplements Regulator

    The US Food and Drug Administration (FDA) has announced the hire of a new leader for its Center for Food Safety and Applied Nutrition, just months after announcing that the center's current leader, Michael Landa, is set to retire. FDA said as of January 2015, Dr. Susan Mayne will assume the position of director, CFSAN from the retiring Landa. Mayne, a scientist by training, has extensive experience in nutrition, toxicology and epidemiology, according to FDA. The agen...
  • Regulatory NewsRegulatory News

    CFSAN Director Michael Landa to Retire, Search on for Successor

    Michael Landa, director of the US Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN)—its food, cosmetics and supplement regulatory body—soon plans to retire from the agency, regulators said Thursday. Landa, a long-time veteran of the agency, first joined FDA in 1978. Prior to serving as CFSAN director, he served as its deputy director for regulatory affairs from 2004 to 2010, and as counsel for several of FDA's regulatory divi...
  • Patient Group Collaborations Continue as Sanofi, Michael J Fox. Foundation Team Up

    • 20 April 2012
    Following in the footsteps of other successful partnerships between pharmaceutical manufacturers and patient groups, French life sciences company Sanofi is teaming up with the Michael J. Fox Foundation (MJFF) to collaborate on testing a new treatment for Parkinson's disease. The partnership will test a compound known as AVE 8112, a phosphodiesterase type 4 inhibitor, in a phase 1 b clinical trial to assess the drug's safety and tolerability, Sanofi said in a statement. ...