Takeaways From FDA's 1st Waiver Decision

Law360, New York (March 8, 2013, 11:45 AM EST) -- On Feb. 22, 2013, the U.S. Food and Drug Administration approved two generic drugs with a risk evaluation and mitigation strategies (REMS) program that differed from the innovator company’s existing REMS program. This decision appears to be the first time that the FDA has waived the requirement for a “single shared system” under Section 505-1 of the federal Food, Drug and Cosmetic Act (FDC Act), which was created by Section 901 of the Food and Drug Administration Amendments Act of 2007 (the FDAAA).

According to the...
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