FDA
News Digest
January
24, 2005
_____________________________________________________
THIS WEEK'S
NEWS
-- FDA Offers
Patient Information on Recently Approved Devices
-- Recalls/Market
Withdrawals
-- Public Meetings
_____________________________________________________
FDA
Offers Patient Information on Recently Approved
Devices
FDA's
Center for Devices and Radiological Health has created consumer information Web
pages for two recently approved medical devices. The pages, linked on the following list,
briefly describe the devices, explain what they are intended to do,
and tell how they should and should
not be used.
-- Charité
Artificial Disc
(for treating pain associated with degenerative disc
disease)
http://www.fda.gov/cdrh/mda/docs/p040006.html
-- Endologic PowerLink System (for treating
abdominal aortic aneurysms)
http://www.fda.gov/cdrh/mda/docs/p040002.html
_____________________________________________________
RECALLS/MARKET
WITHDRAWALS
The following
products are being recalled for the reasons shown. Go to the linked pages for
more information.
Certain lots of
Judy Candy Co.'s Assorted Caramel/Jar 50ps (undeclared almonds)
http://www.fda.gov/oc/po/firmrecalls/judy01_05.html
Kinnikinnick Foods
Inc.'s Gluten-Free Chocolate-Dipped and Cinnamon Sugar Donuts (contains unlisted
soy protein) http://www.fda.gov/oc/po/firmrecalls/kinnikinnick01_05.html
One lot of
Methylin CT, 5 mg. (may contain up to three times the active ingredient)
http://www.fda.gov/oc/po/firmrecalls/alliant01_05.html
Trader Joe's
Shortbread Tea Cookies With Cranberries (may contain undeclared
pecans)
http://www.fda.gov/oc/po/firmrecalls/traderjoe01_05.html
For a listing of
recalls, market withdrawals, and safety alerts from the last 60 days involving
FDA-regulated products, go to http://www.fda.gov/opacom/7alerts.html
___________________________________________________
PUBLIC
MEETINGS
Feb. 16-18 -- Joint Meeting of the FDA Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee: under discussion: benefit-to-risk considerations for COX-2 nonsteroidal anti-inflammatory drugs (Gaithersburg, Md.)
-- FDA Statement: http://www.fda.gov/bbs/topics/news/2005/NEW01151.html
-- Meeting Information: http://www.fda.gov/oc/advisory/accalendar/2005/cder12532ddd0216171805.html
April 27-28 --
11th Annual FDA
Science Forum; includes a free public session on personalizing your healthcare,
and scientific sessions on nanotechnology, animal models, cancer
diagnosis/treatment, risk management, and other topics (Washington, D.C.)
http://www.cfsan.fda.gov/~frf/forum05/sxsf05pr.html
For a list of
upcoming FDA meetings, seminars, and other public events, go
to
http://www.fda.gov/opacom/hpmeetings.html.
____________________________________________
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