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FDA Releases Draft Guidance On Clinical Recommendations For "N of 1" Gene Therapies

To eliminate ineffectiveness due to genetic differences, clinical trials of individual patients, described as an “N of 1”. ....

United States , Jacobj Adashek , Kari Oakes , Peter Marks , Brown Rudnick , Hans Georg Eichler , Janet Woodcock , Eric Topol , Neil Dispirito , Adamm Schoen , Nicholasj Schork , Elizabeth Lillie , Robertb Ruh , Debabrata Mukherjee , Syminj Charpentier , Jane Nikles , Regulatory Affairs Professionals Society Jan , International Collaborative Network , Drug Administration , Severely Debilitating , Life Threatening Diseases , Single Case Designs , One Person Trials , Cardiovascular Diseases , Ultimate Strategy , Personalized Medicine ,

FDA Releases Draft Guidance On Clinical Recommendations For "N of 1" Gene Therapies

To eliminate ineffectiveness due to genetic differences, clinical trials of individual patients, described as an “N of 1”. ....

United States , Jacobj Adashek , Kari Oakes , Peter Marks , Brown Rudnick , Hans Georg Eichler , Janet Woodcock , Eric Topol , Neil Dispirito , Adamm Schoen , Nicholasj Schork , Elizabeth Lillie , Robertb Ruh , Debabrata Mukherjee , Syminj Charpentier , Jane Nikles , Regulatory Affairs Professionals Society Jan , International Collaborative Network , Drug Administration , Severely Debilitating , Life Threatening Diseases , Single Case Designs , One Person Trials , Cardiovascular Diseases , Ultimate Strategy , Personalized Medicine ,