Zdrowie i gospodarka · 19/08/2014

Generic Drug User Fee Amendments of 2012; Public Hearing on Policy Development; Request for Comments

The Food and Drug Administration (FDA) is announcing a public hearing to solicit public comment on certain topics related to implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA), and the GDUFA Commitment Letter that accompanies the legislation. The public hearing also will provide an opportunity for public input on future policy priorities. FDA is seeking participation in the public hearing and written comments from all interested parties, including, but not limited to, regulated industry, consumers, patients, caregivers, health care professionals, and patient groups.