FDA News Digest September 8, 2003 ______________________________________________________________ New Procedures Aim to Modernize Regulation of Drug Manufacturing FDA has announced new steps in its one-year-old initiative to update the regulation of pharmaceutical manufacturing and product quality. The initiative aims to ensure that the agency's regulatory policies are based on state-of-the-art pharmaceutical science and do not hinder industry adoption of new technological advances. Press release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00936.html Further information: http://www.fda.gov/cder/gmp/index.htm ______________________________________________________________ FDA Approves New Oral Contraceptive With 91-Day Dose Schedule FDA has approved Seasonale, a contraceptive pill that is taken daily for 12 weeks, followed by seven days of placebo (inactive) tablets. This 91-day dosing regimen offers women a new choice over conventional oral contraceptives that are based on a 28-day regimen (21 days of active tablets, followed by seven days of placebos). Women taking the new drug typically will have one menstrual period every three months. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01251.html ______________________________________________________________ RECALLS The following products are being recalled for the reasons shown. Go to the linked page for more information. Nut Boy Co. Tropics Mix and Banana Nut Trail Mix; 16-oz. packages (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/nutboy09_03.html Golden Luck Inc. Red Pepper Powder; 1.4-oz. bottles (possible Salmonella contamination) http://www.fda.gov/oc/po/firmrecalls/goldenluck09_03.html Food Connection II Seafood Salad (possible Listeria monocytogenes contamination) http://www.fda.gov/oc/po/firmrecalls/foodconnect09_03.html To view a list of recalls and safety alerts from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html _____________________________________________________________ PUBLIC MEETINGS Sept. 23-24 -- FDA Animal Feed Safety System; Herndon, Va. http://www.fda.gov/cvm/index/conferences/AFSSPubMtg.htm Oct. 15 -- FDA Anti-Counterfeit Drug Initiative; Bethesda, Md. http://www.fda.gov/OHRMS/DOCKETS/98fr/03-22789.htm For a list of other upcoming FDA meetings and public events, go to http://www.fda.gov/opacom/hpmeetings.html _____________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be September 15. 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
