FDA News Digest June 30, 2003 ______________________________________________________________
FDA OKs Dual Packaging of Cholesterol Drug and Buffered Aspirin FDA has approved Pravigard PAC, a co-packaging of the cholesterol-lowering drug Pravachol (pravastatin) and buffered aspirin, as a treatment to reduce the risk of heart attack, stroke, or death in patients who have evidence of disease in blood vessels of the heart or brain. The dual packaging offers a convenience to those who take both drugs. http://www.fda.gov/bbs/topics/nEWS/2003/NEW00917.html ______________________________________________________________ Agency to Post Responses to FDA Warning Letters on Website FDA is planning a six-month pilot program to post recipients' responses to FDA warning letters on the agency's website. Under the program, FDA will post the responses if recipients request the posting and if responses are in an appropriate electronic format. In some cases, FDA may decline to post the responses if the agency determines that the response could mislead the public. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01237.html ______________________________________________________________ Woman Sentenced for Falsely Promoting Spinal Injuries Cure A U.S. district court in Idaho has sentenced Beverly Vigil to 33 months in federal prison and has ordered her to pay back almost $800,000 to victims of a scheme that used the Internet illegally to promote a bogus cure for spinal cord injuries and other serious illnesses. http://www.fda.gov/bbs/topics/nEWS/2003/doj.html ______________________________________________________________ RECALLS The following products are being recalled for the reasons shown. Go to the linked page for more information: Health Nutrition (RMA Labs) Viga or Viga for Women (contains unlabeled drug ingredient sildenafil) http://www.fda.gov/oc/po/firmrecalls/viga6_03.html Sabra Smoked Whitefish Salad (possible Listeria monocytogenes contamination) http://www.fda.gov/oc/po/firmrecalls/whitefish06_03.html African Market (Brochette) Uneviscerated Fish (possible Clostridium botulinum contamination) http://www.fda.gov/oc/po/firmrecalls/africanmkt06_03.html ______________________________________________________________ RECENT SPEECHES FDA Commissioner Mark B. McClellan, M.D., to the Biotechnology Industry Organization (June 23) http://www.fda.gov/oc/speeches/2003/biotechnology0623.html ______________________________________________________________ RECENT TESTIMONY FDA Associate Commissioners William K. Hubbard and John M. Taylor III, before the House Subcommittee on Oversight and Investigations. Topic: "A System Overwhelmed: The Avalanche of Imported, Counterfeit, and Unapproved Drugs in the U.S." (June 24) http://www.fda.gov/ola/2003/importedrx0624.html ______________________________________________________________ PUBLIC MEETINGS July 8 -- "Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical, and Regulatory Challenges," 8 a.m.- 5:30 p.m., Bethesda, Md. http://www.fda.gov/cdrh/meetings/070803.html July 14 -- "SARS Diagnostics: Scientific and Regulatory Challenges," 8 a.m. - 5 p.m., Rockville, Md. http://www.fda.gov/cdrh/meetings/071403.html For a list of other upcoming FDA meetings, seminars, and public events, go to http://www.fda.gov/opacom/hpmeetings.html ______________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be July 7. To leave this list at any time, send an e-mail to [EMAIL PROTECTED] In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
