IN THIS WEEK'S
ISSUE
» News
» Question of the Week
American Red Cross Fined $4.2 Million for Blood Violations
FDA has fined the American Red Cross $4.2 million for failing to comply with federal regulations relating to collection of blood products. Violations include failure to ask appropriate donor questions and not following manufacturer test protocols. FDA has no evidence that the violations caused serious health consequences. The American Red Cross handles about 45 percent of the nation's blood supply.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01447.html
Unapproved 'Supplements' Seized from Florida Company
U.S. marshals have seized $55,000 worth of products from Florida-based Advantage Neutraceuticals L.L.C. after FDA determined that the company had labeled the products as dietary supplements but had promoted them illegally with claims associated with drug products. Included in the seizure were the products Ellagimax capsules, Coral Max capsules, Coral Max Without Iron capsules, and Advanced Arthritis Support capsules. Company marketing promoted the products for serious diseases such as cancer, fibromyalgia, and seizures.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01446.html
Guidance Drafted Regarding New Type of Diagnostic Test
FDA has issued a draft regulatory guidance for industry and clinical laboratories for a new type of diagnostic test that uses complex mathematical formulas to interpret large amounts of gene and protein data to help guide medical decisions. The tests, called in vitro diagnostic multivariate index assays, include those used to diagnose breast cancer, prostate cancer recurrence, cardiovascular disease, and Alzheimer's disease.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01445.html
FDA Proposes Guidelines on Certain Medical Test Ingredients
In response to requests from manufacturers, FDA has published a draft guidance that aims to clarify federal regulations governing the use of medical test ingredients called analyte specific reagents (ASRs). The guidance explains the responsibilities of ASR manufacturers so tests using these ingredients will be safe and effective. ASRs are used in diagnosis of diseases and conditions and to help guide medical decisions.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01444.html
Latest 'Patient Safety News' Video
Available Free
Online
FDA has posted the latest edition of "Patient Safety News," a free Web-based video news program aimed primarily at health professionals. The program features information on new drugs, biologics, and medical devices, as well as FDA safety notifications and product recalls.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm
http://www.fda.gov/opacom/hpnews.html.
To access the RSS feed of FDA news releases, go
to
http://www.fda.gov/bbs/topics/news/rssPress.xml.
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
____________________________________________
http://www.fda.gov/oc/po/firmrecalls/monterey09_08.html
products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.
To access the RSS feed of FDA recalls information, go
to
http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
_____________________________________________
UPCOMING PUBLIC MEETINGS
Sept. 26 -- Risk
Communication on Medical Devices: Sharing Perspectives
Under discussion: how the
government and device industry communicate expected and unexpected risks to
doctors, patients and the public
Location:
http://www.fda.gov/cdrh/meetings/092606-riskcommunication.html
For a list of FDA meetings, seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html.
QUESTION OF THE WEEK
What can you do ahead of time to help reduce food safety risks that could result from storm-related power outages and flooding?
FDA suggests the following:
» Make or buy ice to keep food cold in refrigerators and
freezers in case of a power outage.
» Freeze
refrigerated items such as leftovers, milk, fresh meat and poultry that you may
not need immediately.
» Have coolers on
hand to keep refrigerated food cold if the power will be out for more than 4
hours. Have ice or gel packs ready for use in coolers.
» Keep a supply of
bottled water stored where it will be safe from flooding.
» Get an appliance thermometer to monitor refrigerator and freezer temperatures. Make sure your freezer is at or below 0 degrees F and the refrigerator is at or below 40 degrees F.
Thanks for subscribing to FDA News Digest. Our next posting will be September 18.
To
subscribe to or unsubscribe from this list, go to
http://list.nih.gov/cgi-bin/wa?SUBED1=fda-newsdigest-l&A=1.
__________________________________________________
To learn more about FDA's 100th birthday,
