BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 11.05.2016

Over-the-Counter Monograph User Fees: Public Meeting; Request for Comments

The Food and Drug Administration (FDA) is announcing a public meeting to gather stakeholder input on the potential development of a user-fee program for nonprescription (over-the-counter or OTC) monograph drugs. A user-fee program would provide funding to supplement congressional non-user-fee appropriations, and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph. FDA invites public comment on a potential OTC monograph user-fee program and also invites suggestions regarding the features such a user-fee program should include.

Source: Federal Register — Food and Drug AdministrationOpen original release →