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Life Sciences & Health Care Attorneys Author Bloomberg BNA Article on FDA Easing Burdens on Expanded Access Use

Practices: Health Care, Life Sciences, FDA Regulatory, Clinical Research

Health care partner Mark Barnes (Boston) and life sciences partner Gregory Levine (Washington, D.C.) authored a Nov. 15 article published in Bloomberg BNA’s Medical Research Law & Policy Report, that examines the implementation and consequences of new U.S. Food and Drug Administration (FDA) policies that streamline and reduce administrative delays in the process of applying for expanded access use of investigational drugs, medical devices and biological products.

Expanded access programs allow investigational medical products to be made available outside clinical trials to patients suffering from serious diseases for whom no satisfactory alternative treatment options exist.

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