FDA News
Digest
November 28, 2005
_____________________________________________________
IN THIS
WEEK'S ISSUE
-- FDA Answers Questions about Protective Equipment for Flu Outbreaks
-- Web Pages Give Background on Recently Approved Medical Devices
-- Recalls/Safety
Alerts
-- Upcoming Public
Meetings
-- Question of the
Week
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FDA Answers Questions about Protective Equipment for Flu Outbreaks
FDA has posted a Web page that discusses the use of personal equipment designed to protect healthcare workers during flu outbreaks. In a "Q and A" format, the page reviews the kinds of equipment available, how to determine if FDA has cleared the equipment, and what to watch out for when buying protective equipment.
http://www.fda.gov/cdrh/emergency/flu_qa.html
Web Pages Give Background on Recently Approved Medical Devices
FDA's Center for Devices and Radiological Health has published online consumer information on three recently approved medical devices. The information, linked on the following list, briefly describes the devices:
-- Decapinol Oral Rinse
Intended use: a prescription oral rinse to treat gingivitis (inflammation of the gums)
http://www.fda.gov/cdrh/mda/docs/k041482.html
-- DakoCytomation c-Kit pharmDx
Intended use: to help identify patients with gastrointestinal stromal tumors who could be candidates for selected drug therapy.
http://www.fda.gov/cdrh/mda/docs/p040011.html
-- DuraSeal Dural Sealant System
Intended use: to prevent cerebrospinal fluid from leaking out of the incision site in dura mater surgery
http://www.fda.gov/cdrh/mda/docs/p040034.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:
Safety Alert:
The marketer of Flomax (tamsulosin HCl), a treatment for benign prostatic hyperplasia, has notified health professionals that a condition called intraoperative floppy iris syndrome has been observed in some cataract surgery patients taking Flomax and other alpha-1 blockers.
http://www.fda.gov/medwatch/safety/2005/safety05.htm#Flomax
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
Dec. 1 --
Microarray Quality Control
Project Meeting
Location: Palo Alto,
Calif.
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-21152.htm
Dec. 2 -- Psychopharmacologic Drugs
Advisory Committee
Under
discussion: pending application for a drug to treat attention deficit
hyperactivity disorder
Location:
Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cder12544d120205.html
Dec. 7-8 --
Hearing to
obtain public input on the agency's current risk communications and outreach
strategies, which include patient information sheets, press releases, public
health advisories, and other tools.
Location:
Washington, D.C.
http://www.fda.gov/bbs/topics/answers/2005/ans01367.html
Dec. 7-8 -- Industry Exchange Workshop on FDA's Statutory and Regulatory Requirements for Clinical Trials
Location:
Cincinnati, Ohio
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-18654.htm
Dec. 15 -- Joint FDA/USDA meeting to
discuss a consistent regulatory approach concerning the jurisdiction over
certain products containing meat or poultry.
Location:
Rosemont, Ill.
http://www.fda.gov/bbs/topics/news/2005/NEW01255.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 do I report a bad reaction or other problem related to drugs, biological products, medical devices, food, or cosmetics?
FDA created the MedWatch program to monitor adverse effects and problems with medical products the agency regulates (human drugs and medical devices, for example). MedWatch is a voluntary reporting system available to consumers or health professionals by going to http://www.fda.gov/medwatch/index.html. Click on "How to Report", then "Reporting by Consumers" or "Reporting by Health Professionals." You also can call the FDA Division of Drug Information at 301-827-4573 and request that a MedWatch Voluntary Reporting Form be sent to you.
For problems with vaccines, FDA and the Centers for Disease Control and Prevention maintain the Vaccine Adverse Event Reporting System. To report a vaccine problem online, go to https://secure.vaers.org/VaersDataEntryintro.htm.
For more on reporting problem products to FDA, go to http://www.fda.gov/opacom/backgrounders/problem.html.
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