FDA News Digest
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IN THIS WEEK'S
ISSUE
» News
-- FDA Issues Guidelines to Boost Safety of Fresh-Cut Produce
-- FDA Approves First Skin Patch for Treating Major Depression
-- Colon Cancer Drug Now Approved to Treat Head, Neck Cancer
--
Latest 'Patient Safety News'
Video
Available Online
» Recalls/Safety Alerts
» Recent Speeches
» Upcoming
Public Meetings
»
Question of the
Week
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Guidelines Aim to Help Companies Develop New Flu Vaccines
FDA has issued two draft documents to help manufacturers develop seasonal and pandemic flu vaccines and get them to market quickly. The documents suggest steps companies can take to help expedite approval when developing and submitting clinical data to show vaccine safety and effectiveness. FDA will accept public comments on the two draft documents for 90 days.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01330.html
Response Plan Developed for Food-Related Emergencies
FDA has joined with several state and federal groups to develop a food emergency response plan to enhance protection of the nation's food supply by emphasizing measures such as prevention and detection. A food emergency is a deliberate or unintentional food contamination, threatened or actual, that may affect public health.
FDA Issues Guidelines to Boost Safety of Fresh-Cut Produce
FDA has issued a draft guidance document aimed at minimizing bacterial contamination in fresh-cut fruits and vegetables sold in ready-to-eat form. FDA calls fresh-cut produce "the fastest growing sector of the fresh produce industry." The agency will accept public comments on the draft document for 60 days.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01328.html
FDA Approves First Skin Patch for Treating Major Depression
Emsam (selegiline), a first-of-its-kind once-daily skin patch, has received FDA approval as a treatment for major depression. FDA calls the product "a significant advance" because, at its lowest strength, it can be used without the dietary restrictions needed for oral drugs of this type.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01326.html
Colon Cancer Drug Now Approved to Treat Head, Neck Cancer
FDA has approved Erbitux (cetuximab) for use with radiation therapy to treat patients with squamous cell cancer of the head and neck that cannot be removed by surgery. Erbitux is the first drug approved for this type of cancer to show improved survival. FDA originally approved Erbitux in 2004 to treat colon or rectal cancer that has spread to other parts of the body.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01329.html
Latest 'Patient Safety News' Video
Available Online
FDA has posted the March 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. 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.
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RECALLS/SAFETY
ALERTS
Device Recall:
Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE (for repairing ventral hernias caused by stretching of scar tissue after surgery)
Reason for recall: component in device may break
http://www.fda.gov/cdrh/recalls/recall-122205.html
Drug Recall:
Four lots of Cefazolin for Injection, an antibiotic used in hospitals
Reason for recall: possible microbial contamination
Food Recall:
Certain lots of Arnold's Brownberry Natural Wheat Bread
Reason for recall: undeclared walnuts
http://www.fda.gov/oc/po/firmrecalls/arnold02_06.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
March 3 -- FDA Deputy Commissioner
for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke before the Parenteral Drug
Association's Pharmaceutical Counterfeiting Conference.
Subject: keeping the American drug supply secure
http://www.fda.gov/oc/speeches/2006/pda0303.html
To view an archive
of past speeches by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm.
UPCOMING PUBLIC MEETINGS
March 7-8 -- Peripheral and Central Nervous System Drugs Advisory Committee
Under discussion: risks, benefits, and risk management of the multiple sclerosis treatment Tysabri
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2006/cder12543d030706amd.html
March 8 -- Workshop on Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing
Under discussion: policy to protect the blood supply from transmissible diseases by deferring donors based on high-risk behavior
Location: Bethesda, Md.
http://www.fda.gov/cber/meetings/nat030806.htm
March 9-10 -- Blood Products Advisory Committee
Under discussion: topics include blood donor screening for West Nile virus and home-use HIV test kits
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2006/cber19516dd03091006.html
March 13 -- Oncologic Drugs Advisory Committee
Under discussion: clinical trials for oncologic drugs and a pending application for an ovarian cancer drug treatment
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2006/cder12542d031506amd.html
March 14 -- Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
Under discussion: clinical studies of two pediatric oncology drugs
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2006/cder12542d031406.html
April
18-20 -- 2006
FDA Science Forum; includes sessions on drug safety, obesity, avian flu,
and non-invasive medical devices.
Location:
http://www.fda.gov/scienceforum
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 do FDA advisory committees
do? How can I find out when they
meet?
FDA enlists non-government experts from across the country to help the agency reach decisions, particularly concerning controversial issues or new and unusual products. These "advisory committees" consist of medical professionals, scientists, researchers, industry leaders, consumers, and patients.
To learn more about advisory committees, and to see a list of meeting dates, go to http://www.fda.gov/oc/advisory/default.htm.
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