IN THIS WEEK'S
ISSUE
» News
» Recalls/Safety Alerts
» Recent Speeches
»
Upcoming Public
Meetings
FDA Approves Skin Patch to
Treat ADHD in Children
FDA has approved Daytrana, a once-daily skin patch for treating attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years. FDA calls the patch "an alternate route of administration" for the drug treatment. ADHD affects about three to seven percent of school-aged children in this country.
Contract Will Assess Processes for Postmarketing Commitment Studies
Latest 'Patient Safety News' Video
Available Online
FDA has posted the April edition of "Patient Safety News," a
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.]
Food Recalls:
Limited production run of Duncan Hines Family Style Chewy Fudge Brownies; 21-oz. size; sold only in Northern California, Nevada and Hawaii
Reason for recall: undeclared walnuts
http://www.fda.gov/oc/po/firmrecalls/pinnacle04_06.html
Worthington Vegetable Skallops, 1-lb.4-oz. size
Reason for recall: undeclared egg and milk
http://www.fda.gov/oc/po/firmrecalls/worthington04_06.html
Device Recall:
ACCU-CHEK Ultraflex Infusion Sets for insulin pump therapy
Reason for recall: possible malfunction could interrupt insulin delivery
http://www.fda.gov/oc/po/firmrecalls/disetronic04_06.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.
[What is
an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
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RECENT SPEECHES
March 29 -- FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke at the Harvard University Medical Device Compliance Congress.
Subject: future regulation of medical devices
http://www.fda.gov/oc/speeches/2006/harvard0329.html
To
view an archive of past speeches by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm.
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UPCOMING PUBLIC MEETINGS
April 18-20 -- 2006 FDA Science Forum; includes sessions on drug safety, obesity, avian flu, and non-invasive medical devices. Also planned is a free public session April 18 called "Ask FDA," in which agency scientists will answer questions from consumers about products FDA oversees.
Location:
http://www.fda.gov/scienceforum
April 25 -- Small Pharmaceutical Business Educational Forum
Under discussion: FDA's premarket requirements; good manufacturing practices
Location: Washington, D.C.
http://www.fda.gov/cder/meeting/de-forum-2006.htm
April 25-26 -- Cardiovascular and Renal Drugs Advisory Committee
Under discussion: pending application for a new drug to treat pain associated with anal fissures
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2006/cder12533dd04252606.html
April 28 -- Risk Management, Corrective and Preventive Actions, and Training: An Educational Forum
Under discussion: FDA's quality systems regulation (especially of interest to small businesses)
Location: Dallas
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-23677.htm
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 do I need to consider when buying contact lenses on the Internet, by phone or by mail?
»
Is my contact lens prescription current?
You should always have a current, correct prescription when you order contact
lenses.
» The expiration date for your prescription is currently set by your state. Some require a one-year renewal, some a two-year renewal, while other states leave it to your doctor to decide. Never order lenses with a prescription that has expired.
» If you have not
had a check-up in the last one to two years, you may have problems with your
eyes that you are not aware of, or your contact lenses may not correct your
vision well.
HOW'S YOUR KNOWLEDGE of health topics such as foot health, migraines, and pain medication? Find out by taking our FDA Consumer health quiz at http://www.fda.gov/fdac/quiz/onlinequiz28_js.html.
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To learn more about FDA's 100th birthday,
