FDA News Digest
December 8, 2003
________________________________________________
FDA, Customs Collaborate to Bolster Safeguards on Imported Food
In what FDA calls an "unprecedented" agreement, the agency is collaborating with the U.S. Customs and Border Protection (CBP) on an initiative to improve the safety and security of the nation's food supply. The agreement allows FDA to commission thousands of CBP officers to conduct, on FDA's behalf, investigations and examinations of imported food.
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00988.html
______________________________________________________________
FDA Updates, Clarifies Draft Guidance on Tests for Screening Drugs of Abuse
A revised FDA draft guidance clarifies the agency's regulatory requirements for manufacturers of drug abuse screening tests to help ensure that these tests are used effectively. The guidance describes the types of studies the agency recommends to establish that the tests are reliable. Covered under the guidance are screening tests for amphetamines, cocaine, methamphetamines, opiates, marijuana, and PCP.
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00987.html
_____________________________________________________________
10 People, 3 Firms Indicted for Illegal Internet Medicine Sales
A federal grand jury has returned a 108-count indictment charging 10 individuals and three companies with illegally selling controlled substances and other prescription drugs over the Internet through various websites. Drugs named in the indictment include Viagra, Meridia and Xenical.
Justice Department press release: http://www.usdoj.gov/usao/vae/Pressreleases/chabbra120303.pdf
Indictment: http://www.usdoj.gov/usao/vae/Pressreleases/chabbraindict120303.pdf
_____________________________________________________________
Florida Man Charged With Selling Counterfeit Cholesterol Drug
Julio Cesar Cruz has been charged in federal court with selling more than $1 million worth of counterfeit Lipitor, a prescription drug used widely to lower cholesterol. The charges follow an FDA investigation into counterfeit drugs launched earlier this year.
Justice Department press release: http://www.usdoj.gov/usao/mow/news/cruz.com.pdf
Criminal complaint: http://www.usdoj.gov/usao/mow/news/cruz.complaint.pdf
_____________________________________________________________
FDA Meets With Stakeholders to Get Feedback on Device User Fees
FDA has met with manufacturers and other stakeholders to gather feedback on the implementation of the Medical Device User Fee and Modernization Act of 2002. The law aims to provide sufficient resources to ensure that new medical devices are reviewed for safety and effectiveness as quickly as possible. As part of the law's provisions, FDA plans to add more than 100 new staffers in fiscal year 2004 to help speed the review process.
http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01269.html
_____________________________________________________________
Commissioner Thanks President, Others on Signing of Pediatric Research Act
FDA Commissioner Mark B. McClellan, M.D., has thanked President Bush and several members of both houses of Congress following the signing of the Pediatric Research Equality Act of 2003. The law will allow FDA to require studies to ensure that drugs are safe and effective when used in children.
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00989.html
_____________________________________________________________
Levitt Retires as Head of FDA's Food Center; Brackett to Succeed Him
Joseph A. Levitt, Esq., director of the FDA Center for Food Safety and Applied Nutrition, will retire from the agency on Dec. 31. He will be succeeded by Robert E. Brackett, Ph.D., who most recently has been responsible for FDA food safety policy issues and for coordinating new food safety programs.
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00986.html
_____________________________________________________________
RECALLS/MARKET WITHDRAWALS
The following products are being recalled or withdrawn for the reasons shown. Go to the linked page for more information.
Respironics ComfortGel Mask (some masks missing exhalation port)
http://www.fda.gov/oc/po/firmrecalls/comfortgel12_03.html
Dixon's APAP Acetaminophen 325 mg tablets; 504 bottles (contains excess of labeled amount of acetaminophen)
http://www.fda.gov/oc/po/firmrecalls/magno12_03.html
For an archive of FDA-related recalls and safety alerts from the last 60 days, go to http://www.fda.gov/opacom/7alerts.html.
______________________________________________________________
Thanks for subscribing to FDA News Digest. Our next posting will be
December 15.
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
