FDA News Digest
June 13,
2005
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IN THIS WEEK'S
ISSUE
-- Vaccine OK'd to Protect Adolescents,
Adults Against Whooping Cough
-- Web Site Describes Implanted Devices
That May Help Deaf Patients
-- Recalls/Safety Alerts
-- Recent Speeches
-- Public Meetings
-- Question of the Week
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Vaccine OK'd to Protect
Adolescents, Adults Against Whooping Cough
FDA has approved Adacel,
a combination vaccine to help protect adolescents and adults (ages 11 to
64) against whooping cough (pertussis), diphtheria and tetanus. Adacel is the
first vaccine approved as a whooping cough booster for adults, though vaccines
for preventing diphtheria and tetanus in adults have been available for
years.
http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01361.html
Web Site Describes Implanted
Devices That May Help Deaf Patients
FDA has created an information Web
site to help consumers understand cochlear implants, which are implanted
electronic hearing devices that stimulate nerves within the inner ear. The
implants are designed to produce useful hearing sensations in people with
severe-to-profound nerve deafness who get little or no benefit from hearing
aids. The Web site includes an animated movie to help visualize the implants and
how they work.
http://www.fda.gov/cdrh/cochlear/index.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.
What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.
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RECALLS/SAFETY ALERTS
Recalls :
Certain lots of Publix drinking
water; 1-gal. and 2.5-gal. sizes
Reason for recall: off taste and
odor
http://www.fda.gov/oc/po/firmrecalls/publix06_02.html
Giant Food's Chocolate Chip Ice
Cream, produced for Tops Markets and Giant Food stores; 1/2-gal.
size
Reason for recall: undeclared pecans
due to mislabeling
http://www.fda.gov/oc/po/firmrecalls/giant06_05.html
Fieldcrest Chocolate Ice Cream;
1/2-gal. size
Reason for recall: undeclared
peanuts
http://www.fda.gov/oc/po/firmrecalls/midwest06_05.html
265 cases of Baked! Lay's Original
flavor potato crisps; 1-1/8-oz. size. Recall affects only food service
distribution, not traditional retail outlets such as
supermarkets.
Reason for recall: undeclared dairy
component
http://www.fda.gov/oc/po/firmrecalls/fritolay06_05.html
Coffee Bean & Tea Leaf's Rice
Krispy Treats; 3-oz. size
Reason for recall: undeclared egg
whites
http://www.fda.gov/oc/po/firmrecalls/coffeebean06_05.html
Several dog and cat treats marketed
by T.W. Enterprises and distributed under the name T.W. or Aron Pet
Food
Reason for recall: possible
Salmonella
contamination
http://www.fda.gov/oc/po/firmrecalls/tw06_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
June 8 -- FDA Acting Commissioner Lester
M. Crawford, D.V.M., spoke before the Canada National Food Safety
Summit.
Subject: FDA's measures
to protect the nation's food supply
http://www.fda.gov/oc/speeches/2005/canadafs0608.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 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
June 22-23 -- Circulatory System Devices Panel of
the Medical Devices Advisory Committee
Under discussion: a premarket
approval application for a device intended to treat heart
failure
Location: Gaithersburg,
Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12625dd06222305.html
June 23 -- Obstetrics and Gynecology Devices
Panel of the Medical Devices Advisory Committee
Under discussion: a premarket
approval application for a fetal heart monitoring device
Location: Gaithersburg,
Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12524d062305.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
How can I participate in FDA's
process for making its rules?
In general, any citizen can submit
comments on rules FDA proposes. The agency announces rules in the Federal Register and usually accepts
comments for 60 days. The Federal Register
is available in many libraries or by going to the link below. FDA
urges consumers to participate in the rulemaking process. For more information
about submitting comments, call the FDA Dockets Management Branch at (301)
827-6860.
-- FDA Federal Register page: http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm
-- More on submitting comments to
FDA: http://www.fda.gov/opacom/backgrounders/voice.html
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