FDA News Digest for October 24, 2005

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

Title: Message

FDA News Digest

October 24, 2005

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IN THIS WEEK'S ISSUE

 

--  'Significantly More' Flu Vaccine Likely This Year, FDA Says

--  FDA Warns Fruit Companies to Stop Making Unproven Health Claims

--  Dal Pan Appointed Director of Agency Drug Safety Office

--  Recalls/Safety Alerts

--  Upcoming Public Meetings

--  Question of the Week

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'Significantly More' Flu Vaccine Likely This Year, FDA Says

 

Though FDA can't at this time predict how much flu vaccine will be available for immunizing U.S. consumers in the 2005-06 flu season, the agency anticipates availability of "significantly more" vaccine than in last year's flu season. Some spot shortages may occur in the coming weeks as manufacturers work to complete final testing of their vaccines, the agency says.

http://www.fda.gov/bbs/topics/news/2005/new01243.html

 

FDA Warns Fruit Companies to Stop Making Unproven Health Claims

 

FDA is warning 29 companies to stop making claims that their fruit products can treat or prevent cancer, heart disease, arthritis, and other diseases. FDA considers such claims unproven and in violation of federal regulations. The claims -- being made for dried fruit, fruit juice, and juice concentrate -- are showing up on product labels and company Web sites.

-- Press release:  http://www.fda.gov/bbs/topics/news/2005/new01246.html

-- Warning letters:  http://www.cfsan.fda.gov/~dms/chrylist.html

 

Dal Pan Appointed Director of Agency Drug Safety Office

 

FDA has named Gerald J. Dal Pan, M.D., director of the agency's Office of Drug Safety. He will oversee a program that aims to ensure the safe and appropriate use of medications. Dal Pan brings considerable experience to the job, including a managerial post within the Office of Drug Safety and research positions at Johns Hopkins University.

http://www.fda.gov/bbs/topics/news/2005/new01245.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

 

Boston Scientific ENTERYX Procedure Kits and Injector Single Packs (for treatment of reflux disease)

Reason for recall: reports of improper injection procedures

http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#ENTERYX

 

Certain lots of Prima Qualita brand Meatless Spaghetti Sauce;  106-oz. size

Reason for recall: undeclared cheese

http://www.fda.gov/oc/po/firmrecalls/hirzel10_05.html

 

Baroody Dried Apricots; 400-gram size

Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/baroody10_05.html

 

Certain lots of Home Made Brand Tuna Salad; 5-lb. size

Reason for recall: possible Listeria monocytogenes contamination

http://www.fda.gov/oc/po/firmrecalls/homemade210_05.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

 

Oct. 25-26 -- Advisory Committee for Pharmaceutical Science

Under discussion: Quality-by-Design topics, including drug release or dissolution specifications

Location: Rockville, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cder12539dd10252605.html

 

Oct. 25-26 -- Psychopharmacologic Drugs Advisory Committee

Under discussion: the need for longer-term efficacy data for proposed drug treatments for chronic psychiatric disorders

Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cder12544dd10252605.html

 

Oct. 31 -- Transmissible Spongiform Encephalopathies Advisory Committee

Under discussion: current status of bovine spongiform encephalopathy (BSE or "mad cow disease") in the U.S.

Location: Bethesda, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cber12392d103105.html

 

Nov. 3-4 -- Blood Products Advisory Committee

Under discussion: various topics including West Nile virus and hepatitis C

Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cber19516dd11030405.html

 

Nov. 14 -- Prescription Drug User Fee Act (PDUFA) Public Meeting

Under discussion: stakeholder views as FDA prepares to work on amended authorizing legislation for PDUFA

Location: Bethesda, Md.

http://www.fda.gov/oc/meetings/pdufa111405.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

 

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 a biological product?

 

Biological products (also called biologics) include a wide range such as vaccines, blood and blood components, allergenics, and gene therapy. Biologics can be composed of sugars, proteins, or nucleic acids -- or combinations of these components. Biologics also may be living entities such as cells and tissues. They are isolated from sources such as humans, animals, or microorganisms, and they may be produced by biotechnology or other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research and may be used to treat a variety of medical conditions for which no other treatments are available.

 

For more information on regulation of biologics, see http://www.fda.gov/cber/index.html.

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