Twenty-five intellectual property luminaries sent a letter today to several members of Congress asking them to beware of misleading and inaccurate assertions by “activists and academics” that government price controls on drugs will lead to lower costs for consumers.
FDA reduced the therapeutic equivalence rating for Accord Healthcare s tacrolimus oral capsules due to safety concerns. The generic is still approved and allowed to be prescribed.
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For nearly forty years, the Food and Drug Administration (“FDA”) has required applicants seeking approval of “generic” or “branded generic” drugs under section 505(b)(2) of the Federal.