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Focus on Regulation

Tag Archives: Policy

FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies

On November 16, in the context of announcing a comprehensive regenerative medicine policy framework (discussed here), FDA released a draft guidance document that describes the expedited programs available for the development and review of certain regenerative medicine therapies.  Importantly, the draft guidance clarifies certain aspects of the Regenerative Medicine Advanced Therapy (RMAT) designation established by

FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

Yesterday, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies.  This initiative builds on the agency’s existing framework to set forth more clearly which products are subject to regulatory enforcement. In September, as we previously discussed here and here, FDA’s Commissioner,

Presentation of the Principles of the New Health Bill

Marisol Touraine, French Minister for Health, has presented on Thursday (19 June 2014), during a press conference, the main measures of the proposed new Health bill. The text should be submitted to the French Council of Ministers in September 2014 and should only be examined by the French Parliament (Assemblée Nationale) at the beginning of