FDA News Digest
May 16, 2005
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IN THIS WEEK'S ISSUE
-- First DNA-Based
Blood Test Approved to Detect Cystic Fibrosis
-- FDA Warns of
Counterfeit Drugs Sold in Mexican Pharmacies
-- Recalls/Market
Withdrawals
-- Public
Meetings
-- Question of the
Week
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First DNA-Based Blood Test Approved to Detect Cystic
Fibrosis
FDA has approved the Tag-It Cystic Fibrosis Kit, which analyzes human
DNA to find genetic variations that could indicate the presence of cystic
fibrosis. The test can be used to help diagnose the disease in children and to
identify adults who could be carriers of the genetic variations. In the United
States, cystic fibrosis affects one in 2,500-3,300 Caucasian babies, half of
whom die by age 30.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01178.html
FDA Warns of Counterfeit Drugs Sold in Mexican
Pharmacies
FDA is warning consumers about the sale of counterfeit versions of
Lipitor, Viagra, and an unapproved product called "generic Evista" at pharmacies
in Mexican border towns. The drugs were found to have little or no active
ingredient. FDA urges consumers who have any of these drugs not to use them and
to contact their doctors immediately.
http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01357.html
To view an archive of past FDA news releases, go
to
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
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RECALLS/MARKET WITHDRAWALS
The following products are being recalled for the reasons shown. Go
to the linked pages for more information.
Various 7-Eleven Grilled Sandwich and Big Eats brand sandwiches (possible Listeria monocytogenes contamination)
http://www.fda.gov/oc/po/firmrecalls/prime05_05.html
Tan Nam Fresh Soymilk; 16-oz. and 64-oz. sizes (undeclared cow's
milk)
http://www.fda.gov/oc/po/firmrecalls/tannam05_05.html
Various YTS Group vegetarian products (undeclared
eggs)
http://www.fda.gov/oc/po/firmrecalls/yts05_05.html
Quik'n Tasty Foods Inc.'s Po Boys (lunchmeat, ham and cheese
sandwiches) (possible Listeria monocytogenes
contamination)
http://www.fda.gov/oc/po/firmrecalls/quikntasty05_05.html
Cloud Nine Premium Dark Orange and Dark Chocolate Bar (undeclared
dairy products)
http://www.fda.gov/oc/po/firmrecalls/nspired05_05.html
Jilbert Dairy Vanilla Supreme ice cream; pint and half-gallon sizes
(possible Listeria monocytogenes
contamination)
http://www.fda.gov/oc/po/firmrecalls/jilbert05_05.html
Sino Bestfood Inc.'s 9.88-oz. packages of preserved fruit (apricot)
(undeclared sulfites)
http://www.fda.gov/oc/po/firmrecalls/sino05_05.html
MRL Inc.'s AED 20 Automatic External Defibrillator (possible
malfunction)
http://www.fda.gov/oc/po/firmrecalls/mrl05_05.html
For a list of recalls, market withdrawals, and safety alerts
involving FDA-regulated 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
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PUBLIC MEETINGS
May 17 --
Obstetrics and
Gynecology Devices Panel of the Medical Devices Advisory Committee; under
discussion: a premarket application for a spectroscopy-based cervical imaging
system (Gaithersburg, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12524d051705.htm
May 18-19 --
Drug Safety and
Risk Management Advisory Committee; under discussion: FDA's risk management
program for marketed drugs (Silver Spring, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cder12535dd05181905.html
May 19 --
Antiviral Drugs
Advisory Committee; under discussion: application for approval of a new drug to
treat HIV infection (Gaithersburg, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cder12531d051905.html
May 20 --
Cellular, Tissue
and Gene Therapies Advisory Committee; under discussion: an update on individual
research programs in the Division of Therapeutic Proteins, Center for Drug
Research and Evaluation (Rockville, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cber12389d052005.html
For a list of FDA meetings, seminars, and other public events, go
to
http://www.fda.gov/opacom/hpmeetings.html
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QUESTION OF THE WEEK
What does FDA do with defective
products?
Products found to be unfit for consumers are withdrawn from the
marketplace, either by voluntary recall or by court-ordered seizure. These
products usually are destroyed, or in some cases, they are reconditioned to be
in compliance with FDA regulations.
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