FDA News Digest for February 13, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

Title: Message

FDA News Digest

February 13, 2006

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IN THIS WEEK'S ISSUE

»  News

    --  Report Shows Meeting Early with FDA Helps Drug Review Process

    --  FDA, Industry Group Meet to Discuss Postmarket Safety of Devices

    --  Latest 'Patient Safety News' Video Available Online

»  Recalls/Safety Alerts

»   Upcoming Public Meetings

»  Question of the Week

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Report Shows Meeting Early with FDA Helps Drug Review Process

FDA has released a report showing that meetings between FDA and a drug or biologic sponsor early in the product approval process can improve the efficiency of the review process by boosting the quality of early applications. In fiscal year 2005, FDA received more than 2,400 requests for these meetings.

http://www.fda.gov/bbs/topics/news/2006/NEW01312.html

 

FDA, Industry Group Meet to Discuss Postmarket Safety of Devices

FDA and the Advanced Medical Technology Association met in early February to discuss improving the regulatory oversight of medical devices once they reach the market. The two groups plan future collaborations to help advance this goal.

http://www.fda.gov/bbs/topics/news/2006/NEW01314.html

 

Latest 'Patient Safety News' Video Available Online

FDA has posted the February 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.

[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

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RECALLS/SAFETY ALERTS

 

Food Recalls:

 

Swad Dry Dates; 7- and 14-oz. sizes

    Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/raja02_06.html

 

Ingles Markets' 9" Old Fashion Apple Pie

    Reason for recall: undeclared walnuts

http://www.fda.gov/oc/po/firmrecalls/ingles02_06.html

 

Animal Feed Recall:

 

One lot of Purina Layena Sunfresh Recipe Pellets poultry feed; 50-lb. bags

    Reason for recall: contains excessive salt and doesn't meet company's quality standard

http://www.fda.gov/oc/po/firmrecalls/purina02_06.html

 

Safety Alerts:

 

FDA is alerting doctors who perform heart bypass surgery and their patients that Trasylol (aprotinin injection), used to prevent blood loss during surgery, has been linked to serious side effects such as heart attacks, strokes, and kidney problems in heart bypass patients. FDA advises several actions including toxicity monitoring and limiting use of the drug to when benefit outweighs risk.

http://www.fda.gov/bbs/topics/news/2006/NEW01311.html

 

Consumers should stop using liquid-filled children's teething rings made by RC2 Brands (The First Years), FDA warns, because the liquid in the product is contaminated with bacteria that could cause serious illness if it is swallowed, enters the lungs, or absorbed through a cut. Illness risk is especially high in infants whose immune systems are compromised.

http://www.fda.gov/bbs/topics/news/2006/NEW01313.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

 

Feb. 17 -- Vaccines and Related Biological Products Advisory Committee

    Under discussion: selection of strains to be included in the flu virus vaccine for 2006-2007

    Location: Bethesda, Md.

http://www.fda.gov/oc/advisory/accalendar/2006/cber12391d021706.html

 

April 18-20 -- 2006 FDA Science Forum; includes sessions on topics that include drug safety, obesity, avian flu, and non-invasive medical devices.

    Location: Washington, D.C.

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 is a generic drug?

 

A generic drug is a copy of a brand-name drug that is the same in dosage, safety, strength, how it is taken, quality, performance and intended use.

 

As with brand-name drugs, FDA requires that generic drugs be safe and effective. Generic drugs must have the same quality, strength, purity and stability as brand-name drugs. Because generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.

 

For more on generic drugs, see http://www.fda.gov/cder/ogd/. 

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