The End of Enforcement Discretion for Cell & Gene Therapies: Thinking Through Next Steps

Published date04 June 2021
Subject MatterFDA,Human Genes,Public Health Service Act,PDUFA,FD&C Act,Investigational New Drug Application (IND),Center for Biologics Evaluation and Research (CBER)
AuthorElaine Tseng,Christina Markus,Eva Temkin,Jonathan Trinh
Law FirmKing & Spalding

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