Zdrowie i gospodarka · 06/10/2016

FDA Issues Final Rule on Abbreviated New Drug Applications and 505(b)(2) Applications

The US Food and Drug Administration (FDA) has released a final rule to implement changes to the approval process for certain prescription drugs, including the provision of notice to patent holders and the availability of 30-month stays of approval, as mandated by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).