FDA News
Digest
August 8, 2005
__________________________________________________
IN THIS WEEK'S ISSUE
-- Summary of Drug Safety Oversight Board Meeting Posted
-- Latest 'Patient Safety News' Video Now Available Online
-- Recalls/Safety Alert
-- Public Meetings
-- Question of the
Week
__________________________________________________
Summary of Drug Safety Oversight Board Meeting Posted
To help keep the public informed about the activities of its Drug Safety Oversight Board, FDA has posted a summary of the board's July 27 meeting. The board, which was created to oversee emerging drug safety issues, has met twice since forming and is scheduled to convene about every six weeks. FDA is posting meeting summaries because the board's meetings are not open to the public, due to the proprietary nature of some of the information discussed.
-- FDA statement: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01217.html
-- Meeting summaries: http://www.fda.gov/cder/drug/DrugSafety/DSOBmeetings/default.htm
Latest 'Patient Safety News' Video Now Available Online
FDA has posted the August 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. Though the program can be viewed through either of two common desktop players, the Web site also contains the text of the program.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm
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.]
___________________________________________________
RECALLS/SAFETY ALERTS
Safety Alert:
FDA has notified health care professionals about the possibility of serious complications associated with the use of metallic tracheal stents in patients with benign airway disorders. FDA is concerned about potential complications that include infection and stent fracture. The agency is proposing ways to prevent or minimize the problems.
http://www.fda.gov/cdrh/safety/072905-tracheal.html
Recall:
Four varieties of Perrigo Co.'s infant oral drops with dosing syringe
Reason for recall: syringe may be confusing, leading to improper dosing
-- Recall notice press release: http://www.fda.gov/oc/po/firmrecalls/perrigo07_05.html
-- FDA Safety Alert press release: http://www.fda.gov/bbs/topics/answers/2005/ans01364.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.]
__________________________________________________
Aug. 9 -- General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee
Under discussion: the potential for disease transmission by multiple-use nozzle jet injectors
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12520d080905.html
Aug. 13 -- Public meeting: Quantitative Risk Assessment on the Public Health Impact of Vibrio parahaemolyticus in Raw Oysters
Location: Point Clear, Ala.
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-14294.htm
Aug. 19 -- Public meeting: Request for Comments on Gluten-Free Labeling of Foods
Location: College Park, Md.
http://www.cfsan.fda.gov/~lrd/fr050719.html
For a list of FDA meetings,
seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html.
__________________________________________________
QUESTION OF THE
WEEK
How does FDA regulate infant formulas?
The
safety and nutritional quality of infant formulas are ensured by requiring
that companies follow
specific manufacturing procedures. In
fact, a law -- known as the Infant Formula Act -- was passed in 1980 giving FDA special
authority to create and enforce standards for commercial infant formulas.
Manufacturers must analyze each batch of formula to check nutrient levels
and product safety. They must then
test samples to make sure the product remains in good condition while it is on
the market shelf. Infant formulas must also have codes on their containers to
identify each batch and manufacturers must keep very detailed records of
production and analysis.
___________________________________________________
Thanks for subscribing to FDA News
Digest. Our next posting will be August 15.
To subscribe to or unsubscribe from
this list, go to
