CDER'S RISK-COMMUNICATION STRATEGIES TO BE FOCUS OF HEARING

The Center for Drug Evaluation and Research's (CDER) risk communication strategy for human drugs will be the topic of a two-day public hearing in early December that will focus on collecting public feedback on the effectiveness of the center's communication activities.

The hearing, scheduled for Dec. 7-8 in Washington, D.C., is part of the agency's ongoing effort to improve its risk-communication program. "The purpose of the hearing is to obtain public input on CDER's risk communication tools, identify stakeholders for collaboration and implementation, and obtain greater understanding of the strengths and weaknesses of CDER's existing risk communication," states a recent FDA notice in the Federal Register.

The FDA said it is especially interested in receiving feedback from stakeholders on the following risk-communication tools: patient information sheets, healthcare professional information sheets, talk papers, public health advisories, press releases, MedWatch listserv safety updates, CDER educational campaigns and the CDER website.

The meeting will not address several of the more controversial risk-communication issues facing the FDA and industry, including industry promotional materials, drug labeling and the FDA's proposed Drug Watch website. "Comments have been solicited on these issues at other times in separate proceedings," the FDA's notice states.

To view the hearing announcement, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/05n-0394-nm00001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/05n-0394-nm00001.pdf).