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Full-Text Articles in Consumer Protection Law
Holding Investment Bankers Liable For Aiding And Abetting Corporate Directors: The Under-Deterrent, Maren Worley
Holding Investment Bankers Liable For Aiding And Abetting Corporate Directors: The Under-Deterrent, Maren Worley
Brigham Young University Journal of Public Law
No abstract provided.
Trading Safety For Innovation And Access: An Empirical Evaluation Of The Fda’S Premarket Approval Process, George Horvath
Trading Safety For Innovation And Access: An Empirical Evaluation Of The Fda’S Premarket Approval Process, George Horvath
BYU Law Review
Congress created the premarket approval process (PMA) to provide a rigorous safety evaluation of high-risk medical devices before they may be sold on the U.S. market. Evaluating a PMA application requires the Food and Drug Administration (FDA) to conduct a lengthy, complex, and costly assessment of the extensive data a manufacturer must submit. But other policy concerns, notably a fear of hampering innovation and a desire to assure timely access to new technologies, have led Congress to relax some of the rigorous data requirements the PMA process imposes on manufacturers. Congress mandates that the FDA employ the “least burdensome” approach …