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Stem cells Food and Drug Administration (FDA) Draft Guidance

Foley & Lardner LLP

FDA Releases Stem Cell Guidance Documents

Foley & Lardner LLP on

Therapies that use autologous or allogeneic stem cells are examples of early personalized therapies. Removing cells from a patient and reintroducing them to the same or a matched patient, for example, as done in bone marrow...more

Hogan Lovells

FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies

Hogan Lovells on

On November 16, in the context of announcing a comprehensive regenerative medicine policy framework, FDA released a draft guidance document that describes the expedited programs available for the development and review of...more

Foley & Lardner LLP

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

Foley & Lardner LLP on

Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more

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