CDER Launches Drug Safety Newsletter
October 2, 2007On September 18, 2007, FDA’s Center for Drug Evaluation and Research (“CDER”) launched its latest publication, the “Drug Safety Newsletter”. This quarterly electronic publication is intended as an additional source of drug safety information for healthcare professionals and complements existing communications targeted at healthcare professionals (i.e., prescription drug labeling, Healthcare Professional Sheets, FDA Alerts, and other information available on FDA’s website).
With its new Drug Safety Newsletter, CDER hopes to “enhance communication of new drug safety information, raise awareness of reported adverse events, and stimulate additional adverse event reporting.” Each newsletter will include postmarketing safety information obtained from the Agency’s review of adverse event reports, and from clinical trials and epidemiological studies, postmarketing safety information for “recently approved new molecular [entities]” and “recent advisories on drug safety that have been posted on FDA’s Web site.” In addition to these recurring items, FDA plans to include “topics of special interest.”
The first issue of the Drug Safety Newsletter includes postmarketing reviews of Rituximab, Modafinal, and Temozolamied, early safety findings of the new molecular entity Deferasirox, and FDA’s advisories on drug safety from January 1, 2007 through June 1, 2007.
The electronic newsletter is free. Anyone interested in receiving a copy can subscribe here.