Zdrowie i gospodarka · 06/02/2015

FDA Proposes Regulations for Abbreviated New Drug Applications and 505(b)(2) Applications

The FDA is proposing new rules to implement provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which govern the approval process for certain medications, including abbreviated new drug applications and 505(b)(2) applications, and the provision of notice to patent holders regarding patent certifications made by applicants.