Pharmaceutical Safety Public Hearing
The United States Federal Drug Administration (FDA) will hold a pharmaceutical safety public hearing Dec. 7-8, 2005, at 8 a.m. to 4:30 p.m. in Washington, D.C.
FDA officials believe it is critical that risk communication be timely, accurate and easily accessible. It must also recognize health literacy limitations and include the needs of a multicultural population. The FDA is hosting the hearing to obtain public input on the Center for Drug Evaluation and Research's (CDER) risk communication tools. The FDA will identify stakeholders for collaboration and implementation of additional tools. It also seeks to obtain understanding of the strengths and weaknesses of CDER's existing risk communication.
The Part 15 public hearing will address six questions on documents currently distributed by the FDA. These questions will help the FDA learn which tools are effective and how these risk communications can be improved. The tools include patient information sheets, healthcare professional information sheets, public health aviaries, press releases, MedWatch Listserv Safety Updates, patient safety news, CDER educational campaigns, and the CDER Web site.
To provide oral comments, you must register by Nov. 7 at
http://sacserv.com/links.jsp?linkid=2333& subid=2098788&custid=76campid=143798&type=0
Submit written or electronic notices of participation and comments to:
FDA Division of Dockets Management (HFA-305)
5630 Fishers Ln, Rm 1061
Rockville, MD 20852
fdadockets@oc.fda.gov