FDA News Digest
August 14,
2006
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IN THIS WEEK'S
ISSUE
» News
-- FDA Approves First Generic Version of Depression Drug
Effexor
-- Agency Seeks Comments on New Medical Device
Identifiers
-- Task Force to Advise
Best Regulatory Approaches for
Nanotechnology
-- FDA Clarifies Journal Article on Automated External
Defibrillators
-- Three Pharmacies Warned to Stop Making Unapproved
Inhalation
Drugs
»
Recalls/Safety
Alerts
» Congressional
Testimony
»
Upcoming Public
Meetings
» Question of
the Week
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NEWS
FDA Approves First Generic Version of
Depression Drug Effexor
FDA has approved the first generic version of Effexor
(venlafaxine), a treatment for major depressive disorder (MDD).
Buying generic versions of this drug can result in
significant savings for the millions of Americans diagnosed with
MDD.
Agency Seeks Comments on New Medical
Device Identifiers
FDA is seeking information on how a unique device
identifier (UDI) system for medical devices could reduce medical
errors, facilitate product recalls, and improve reporting of adverse events. The
agency hopes a UDI system will help improve the collection of safety data after
devices are marketed. FDA will accept comments related to UDIs for 90
days.
Task Force to Advise
Best Regulatory Approaches for
Nanotechnology
FDA has created an internal task force
that aims to help the agency evaluate possible adverse health
effects from FDA-regulated products that use nanotechnology materials.
Nanotechnology is the understanding and control of matter in the realm of 1
to 100 nanometers (by comparison, a human hair is 80,000 nanometers
wide). The task force's activities will include a public meeting Oct. 10
that is designed to help FDA further
its understanding of nanotechnology developments related to
FDA-regulated products.
FDA Clarifies Journal Article on Automated
External Defibrillators
FDA has issued a statement listing points in a
recent article about automated external defibrillators (AEDs) in the
Journal of the American Medical Association on which the agency
disagrees. For example, FDA disagrees with the
article's assertion that manufacturers are unable to track AEDs. On the
contrary, FDA says, AED makers are required to track the devices and have
processes in place to accomplish this tracking.
Three Pharmacies Warned to Stop Making
Unapproved Inhalation Drugs
FDA has warned three companies to stop manufacturing
and distributing thousands of doses of unapproved inhalation drugs, which are
used to treat diseases such as asthma and bronchitis. The agency is concerned
that these drugs, compounded at the pharmacy, are not reviewed for safety and
effectiveness. Thus, they may not follow good manufacturing practice and may not
be sterile.
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
Food Recalls:
Some
lots of SuperTarget and Archer Farms brand Mini Angel Food
Cakes
Reason for recall: undeclared egg
ingredient
Safety
Alert:
FDA is warning consumers
not to eat raw clams harvested in the Pacific Northwest because
of an unusual increase in illness caused by the bacterium Vibrio
parahaemolyticus. The warning follows a similar alert last month when FDA
advised consumers to avoid oysters from the
Pacific Northwest.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01430.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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UPCOMING PUBLIC MEETINGS
Aug.
23-24 -- Industry Exchange
Workshop on FDA Clinical Trial
Requirements
Under discussion: industry and FDA
perspectives on proper conduct of FDA-regulated clinical
trials
Location: Brooklyn Park,
Minn.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-8896.htm
Aug. 24-25 --
General and Plastic Surgery Devices Advisory
Committee
Under
discussion: pending review of injectable material proposed to restore soft
tissue facial contours
Location: Gaithersburg, Md.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=628
Aug. 29 --
Reproductive Health Drugs Advisory
Committee
Under
discussion: pending review of a drug to prevent preterm delivery in women with
history of preterm delivery
Location: Gaithersburg, Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-11538.htm
Aug. 29 -- Obstetrics and Gynecology
Devices Panel of the Medical Devices Advisory
Committee
Under discussion: application for a
device that would complement clinical breast examination in
asymptomatic women, ages
30-39
Location: Gaithersburg,
Md.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=664
Sept. 6-7 -- Joint meeting of
Dental Products Panel of the Medical Devices Advisory Committee and the
Peripheral and Central Nervous System Drugs Advisory
Committee
Under discussion: dental amalgam
devices
Location: Gaithersburg,
Md.
http://www.fda.gov/oc/advisory/accalendar/2006/cdrh12518dd09060706.html
Sept. 26 -- Risk Communication on
Medical Devices: Sharing
Information
Under discussion: how the government
and device industry communicate expected and unexpected risks to doctors,
patients and the public
Location: North Bethesda,
Md.
http://www.fda.gov/cdrh/meetings/092606-riskcommunication.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 is the proper temperature for
your refrigerator?
Refrigerators
should stay at 41° F (5° C) or below. That temperature range will slow the
growth of most bacteria. It won't kill the bacteria, but it will keep them from
multiplying, and the fewer there are, the less likely you are to get sick from
them.
Freezing at
zero degrees F (minus 18 °C) or less stops bacterial growth, although it won't
kill all bacteria already present.
For more on
food safety, see http://www.foodsafety.gov/.
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How's your knowledge of health topics such
as the flu, cold medicines, artificial
sweeteners, and smoking? Find out by taking our FDA Consumer health quiz at http://www.fda.gov/fdac/quiz/onlinequiz30_js.html.
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