Global Labeling 2014: Compliance in a Changing Regulatory Environment

In this session, plain language labeling will be discussed. Speakers will highlight the draft, published regulations concerning plain language labeling, an attempt to make drug labeling understandable by focusing on five targeted amendments which will provide: 1) a requirement for clear understandable, plain language labels; 2) required label mock-ups at time of review; 3) look-alike, sound-alike brand name assessments; 4) label contact information to report problems; and 5) a standard table format for key label information for nonprescription drugs. This session will also cover the final guidance, Labeling of Pharmaceutical Drugs for Human Use, highlighting changes from the 2010 draft and key points.