IN THIS WEEK'S
ISSUE
» News
-- Prograf Approved to Prevent Rejection of Heart Transplant
-- Generic Three-Drug Regimen Tentatively OK'd for AIDS Relief
-- Court-Ordered Injunction Ends Illegal Rx Drug Imports
-- '05 Achievements Include Performance Boost in Key Areas
-- Lushniak Promoted to Ass't Surgeon General and Rear Admiral
» Recalls/Safety Alerts
» Recent Speeches
»
Upcoming Public
Meetings
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01341.html
First Generic Capsule Form of HIV/AIDS Drug Approved
FDA has approved the first generic capsule dosage form of the HIV/AIDS treatment zidovudine for marketing in the United States. Previously sold under the trade name Retrovir, generic zidovudine should, says FDA Acting Commissioner Andrew von Eschenbach, M.D., "help reduce the cost of this therapy for American patients."
http://www.fda.gov/bbs/topics/news/2006/NEW01343.html
Generic Three-Drug Regimen Tentatively OK'd for AIDS Relief
FDA has tentatively approved a packaging of generic versions of three drugs used together to treat HIV/AIDS. The tentative approval means that though existing patents or exclusivity agreements prevent U.S. marketing of the product, the packaged treatment meets FDA's standards for quality, safety, and effectiveness. The generic package will now be available for use outside the United States under the President's Emergency Plan for AIDS Relief.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01346.html
Court-Ordered Injunction Ends Illegal Rx Drug Imports
A New York district court has imposed a permanent injunction on Canada Care Drugs Inc. that bars the company from importing and marketing prescription drugs. The injunction is the result of a legal process begun in 2004 after FDA made undercover buys of illegal prescription drugs from Canada Care that bypassed consumer safety protections inherent in the U.S. distribution system.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01345.html
http://www.fda.gov/bbs/topics/news/2006/NEW01342.html
Lushniak Promoted to Ass't Surgeon General and Rear Admiral
Boris D. Lushniak, M.D., an assistant FDA commissioner, has been promoted to assistant surgeon general and to the rank of rear admiral in the Commissioned Corps of the Public Health Service. Before coming to FDA in 2004 to work in counterterrorism policy, Lushniak spent 16 years at the Centers for Disease Control and Prevention working in areas such as disaster response, medical epidemiology, and occupational skin diseases.
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.]
Food Recalls:
Anthony-Thomas Candy Co.'s Filled Easter Eggs; 6- and 12-oz. sizes
Reason for recall: undeclared egg whites and yellow color #5 and 6
http://www.fda.gov/oc/po/firmrecalls/anthony03_06.html
Nestlé Country Creamery Toll House Chocolate Chip and French Vanilla ice cream flavors; sold in Texas Wal-Marts
Reason for recall: undeclared egg
http://www.fda.gov/oc/po/firmrecalls/nestle03_29.html
Eclipse 87%, Los Rios 68%, and Prima Matera 100% dark chocolate products
Reason for recall: high lead levels
http://www.fda.gov/oc/po/firmrecalls/dagoba03_06.html
Device Recall:
Four models of Ossur's Total Knee prosthetic device
Reason for recall: faulty pins in the device
http://www.fda.gov/oc/po/firmrecalls/ossur03_06.html
Safety Alert:
FDA is advising epilepsy patients and their caregivers of a possible hazard created by cracks in the applicator tips of Diastat AcuDial (diazepam rectal gel). The cracks could cause gel leakage during application, resulting in the patient getting insufficient medication.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01348.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 21 -- FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke at the Pacific Northwest Annual Biotechnology Meeting.
Subject: medical innovations in recent history
http://www.fda.gov/oc/speeches/2006/pnab0321.html
To
view an archive of past speeches by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm.
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UPCOMING PUBLIC MEETINGS
April 5 -- Workshop on food labeling
Under discussion: FDA food-labeling regulations, especially of interest to small businesses
Location: Fayetteville, Ark.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E5-8225.htm
April 18-20 -- 2006 FDA Science Forum; includes sessions on drug safety, obesity, avian flu, and non-invasive medical devices. Also planned is a free public session April 18 called "Ask FDA," in which agency scientists will answer questions from consumers about products FDA oversees.
Location:
http://www.fda.gov/scienceforum
April 25 -- Small Pharmaceutical Business Educational Forum
Under discussion: FDA's premarket requirements; good manufacturing practices
Location: Washington, D.C.
http://www.fda.gov/cder/meeting/de-forum-2006.htm
April 25-26 -- Cardiovascular and Renal Drugs Advisory Committee
Under discussion: pending application for a new drug to treat pain associated with anal fissures
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2006/cder12533dd04252606.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
Are there
any FDA-regulated products currently on the market that use
nanotechnology?
FDA
is aware of several regulated products that employ nanotechnology, an emerging technology undertaken at scales in the
realm of 1/1,000th the width of a human hair. However, to date, few
makers of FDA-regulated products have claimed the use of
nanotechnology in the manufacture of their products or made any nanotechnology
claims for the finished products. FDA is
aware that some cosmetic products
claim to contain nanoparticles to increase the stability or modify release of
ingredients. Similarly, FDA is aware of
nanotechnology-related claims made for certain sunscreens. Though currently
not aware of any safety concerns with these products, FDA plans studies to
examine the effects of select nanoparticles on skin penetration.
For more on FDA's regulation of nanotechnology, see http://www.fda.gov/nanotechnology/.
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