FDA News Digest June 16, 2003 ______________________________________________________________ New Rule Aims to Lower Drug Costs and Improve Access to Generics FDA has announced a final rule that will streamline the process for making generic drugs available to consumers more quickly. New review procedures will help improve the speed and reduce the cost of determining that a new generic drug is safe and effective. FDA estimates that the changes will save $35 billion over 10 years. http://www.fda.gov/oc/initiatives/generics/default.htm ______________________________________________________________ Prairie Dogs, African Rodents Prohibited in Move to Curb Monkeypox FDA and the Centers for Disease Control and Prevention will enforce a federal ban on the import of all rodents from Africa due to the potential for these animals to spread the monkeypox virus to other animals and humans. The action includes a ban within the United States on the sale, distribution, or transport of prairie dogs and six African rodents that have been implicated in the recent monkeypox outbreak. Press release: http://www.hhs.gov/news/press/2003pres/20030611a.html Monkeypox information page: http://www.fda.gov/oc/opacom/hottopics/monkeypox.html ______________________________________________________________ FDA, FTC Take Action Against Marketers of Coral Calcium Supplements As part of a federal program to crack down on products with unsubstantiated health claims, FDA and the Federal Trade Commission have taken action against the marketers of Coral Calcium Supreme, a dietary supplement falsely promoted as treating or curing cancer and other diseases. http://www.ftc.gov/opa/2003/06/trudeau.htm ______________________________________________________________ Comment Period Extended on Drug, Biologic Safety Reporting Rule FDA is extending until Oct. 14, 2003, the comment period for a proposed rule to change the agency's pre- and post-marketing safety reporting requirements for human drugs and biologics. The comment period initially was to end July 14. http://www.fda.gov/oc/opacom/extension.html ______________________________________________________________ RECALLS The following products are being recalled for the reasons shown. Go to the linked page for more information: Pet Brand Butter Pecan Ice Cream (labeling error) http://www.fda.gov/oc/po/firmrecalls/landosun06_03.html Cora Brand Paprika (possible Salmonella contamination) http://www.fda.gov/oc/po/firmrecalls/casaimports06_03.html ADCO USA Dried Octopus (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/adco06_03.html Asian Boy Brand Lotus Rootlets (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/bcntrading06_03.html ______________________________________________________________ RECENT SPEECHES FDA Commissioner Mark B. McClellan, M.D., to the Commonwealth Club, San Francisco (June 9) http://www.fda.gov/oc/speeches/2003/commonwealth0609.html FDA Deputy Commissioner Lester M. Crawford, D.V.M., to the American Enterprise Institute (June 12) http://www.fda.gov/oc/speeches/2003/aei0612.html ______________________________________________________________ PUBLIC MEETINGS For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html ______________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be June 23. To leave this list at any time, send an e-mail to LISTSERV@xxxxxxxxxxxx In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
