FDA News Digest
June 6,
2005
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IN THIS WEEK'S
ISSUE
-- FDA Investigates Florida Illness Outbreak Tied to Fresh Basil
-- Latest 'Patient Safety News' Video Now Online
-- Recalls/Safety
Alerts
-- Recent
Speeches
-- Public Meetings
-- Question of the Week
-- Take Our
Quiz
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Latest 'Patient Safety News' Video Now Online
FDA has posted the June edition of its "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. Though the video program can be viewed through either of two common desktop players, the Web site also includes a transcript of the program.
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.
What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.
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RECALLS/SAFETY ALERTS
Recalls :
Children's Tylenol Meltaways (80 mg. doses in bottles and blister packs), Children's Tylenol Soft Chews (80 mg.doses in blister packs), and Junior Tylenol Meltaways (160 mg. doses in blister packs)
Reason for recall: package design and label information could be confusing and lead to improper dosing
http://www.fda.gov/oc/po/firmrecalls/mcneil05_05.html
770 cases of 7-oz. cans of non-dairy Flavor Right (Parve) Whipped Topping; product code #72205
Reason for recall: undeclared dairy component
http://www.fda.gov/oc/po/firmrecalls/alamance05_05.html
Keikito Muffins, packaged in 8-oz. plastic-wrapped styrofoam trays, coded May 2, 2005
Reason for recall: undeclared milk
http://www.fda.gov/oc/po/firmrecalls/jessica05_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.
What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.
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RECENT SPEECHES
May 26 -- FDA Acting Commissioner Lester M.
Crawford, D.V.M., spoke before the Third Conference on International
Harmonization of Veterinary Medicinal Products.
Subject: the harmonization process for veterinary medicinal products
http://www.fda.gov/oc/speeches/2005/vich0526.html
May 20 -- FDA Acting Commissioner Lester M. Crawford, D.V.M., spoke before the Whole Grains & Health Global Summit.
Subject: whole-grain health claims
http://www.fda.gov/oc/speeches/2005/wholegrains0520.html
To view an archive of past speeches by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm.
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PUBLIC
MEETINGS
June 6 -- Pulmonary-Allergy Drugs Advisory
Committee
Under discussion: new drug application
for cyclosporine inhalation solution for patients receiving lung
transplants.
Location: Rockville,
MD
http://www.fda.gov/oc/advisory/accalendar/2005/cder12545d060605.html
June 8 -- Gastroenterology and Urology Devices
Panel of the Medical Devices Advisory Committee
Under discussion: FDA's Critical
Path Initiative and issues related to postmarket study
design.
Location: Gaithersburg,
Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12523d060805.html
June 10 -- Advisory Committee on Special
Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides
and Contaminants
Under discussion: the possibility of
a comprehensive study report derived from an Air Force Health
Study.
Location: Rockville,
Md.
http://www.fda.gov/oc/advisory/accalendar/2005/nctr12560d061005.html
June 13-14 -- Workshop on Biological Products for
Treatment of Rare Plasma Protein Disorders
Under discussion: scientific
and regulatory challenges in development of these
products.
Location: Bethesda,
Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-9011.htm
June 15-16 -- Eighth Annual FDA-Orange County
Regulatory Affairs Educational Conference: "Reality of Regulatory
Affairs"
The conference is an opportunity for
drug, biologics and medical device representatives to interact with FDA
reviewers and compliance officers.
Location: Irvine,
Calif.
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-8050.htm
June 15-16 -- Cardiovascular and Renal Drugs
Advisory Committee
Under discussion: labeling of
hypertensive drugs and a pending application for a new drug proposed to
treat heart failure
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cder12533dd06151605.html
June 17 -- Neurological Devices Panel of the Medical Devices Advisory Committee
Under discussion: FDA's Critical Path Initiative
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12513d061705.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
Does FDA regulate illegal drugs?
Controlling the illegal use of "street" drugs such as heroin, cocaine and marijuana is the job of the federal Drug Enforcement Administration (www.usdoj.gov/dea/). However, if a street drug were to be studied for legitimate medical uses, FDA would regulate it as an investigational drug. FDA-regulated prescription drugs such as barbiturates and amphetamines are sometimes abused and wind up as street drugs. These cases then fall into DEA's jurisdiction.
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TAKE OUR QUIZ
How's your knowledge of health topics such as dieting, hearing loss, or human tissue transplants? Find out by taking our FDA Consumer quiz at http://www.fda.gov/fdac/quiz/onlinequiz23_js.html.
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