FDA News Digest for January 22, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

January 22, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- Agency Guidelines Aim to Streamline Cord Blood Licensing

    -- FDA Commissioner Announces High-Level Agency Changes

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

Agency Guidelines Aim to Streamline Cord Blood Licensing

FDA has drafted guidelines the agency says should make the licensing process "less burdensome" for manufacturers of cord blood for certain medical conditions. Cord blood is used to replenish bone marrow in patients with blood-based malignancies such as leukemia. FDA is accepting comments on the guidelines for 90 days.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01548.html

 

FDA Commissioner Announces High-Level Agency Changes

FDA is creating the Office of the Chief Medical Officer to oversee the agency's scientific operations, FDA Commissioner Andrew C. von Eschenbach, M.D., announced. Janet Woodcock, M.D., a 20-year FDA veteran who has held several high-level agency posts, will head the new office. At the same time, the agency has appointed John R. Dyer as its deputy commissioner for operations and chief operating officer. He has held several previous executive positions, including ones at the Centers for Medicare and Medicaid Services and the Social Security Administration.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01549.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

Dietary Supplement Recall:

 

Liviro3, 10-tablet boxes or 20-tablet bottles

    Reason for recall: FDA found the product to contain tadalafil, an approved erectile dysfunction drug, making Liviro3 an unapproved drug

http://www.fda.gov/oc/po/firmrecalls/ebek01_07.html

 

Food Recall:

 

Tastefully Simple Dried Tomato & Garlic Pesto, 3-oz. jars and sample packets

    Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/tastefully01_07.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

Jan. 23-24 -- Reproductive Health Drugs Advisory Committee

    Under discussion: oral and non-oral hormonal contraceptives

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-21949.htm

 

Jan. 26 -- Neurological Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for a medical device that treats depression

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-20552.htm

 

Feb. 7-8 -- Industry Exchange Workshop on FDA Clinical Trial Requirements

    Under discussion: various aspects of establishing and conducting clinical trials including ethics, informed consent, and FDA's role

    Location: San Diego

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-21138.htm

 

Feb. 9 -- Medical Devices 101: An Educational Forum

    Under discussion: FDA's medical device requirements for entrepreneurs, startup companies, and small businesses.

    Location: Dallas

http://www.fda.gov/OHRMS/DOCKETS/98fr/07-92.htm

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 information must a manufacturer disclose on the label of a dietary supplement?

FDA regulations require certain information to appear on dietary supplement labels, including:

•  a descriptive name of the product, stating that it is a "supplement"
•  the name and place of business of the manufacturer, packer, or distributor
•  a complete list of ingredients
•  the net contents of the product.

In addition, each dietary supplement -- except for some small-volume products or those produced by eligible small businesses -- must have nutrition labeling in the form of a "Supplement Facts" panel. This label must identify each dietary ingredient contained in the product.

For more on dietary supplements, see http://www.cfsan.fda.gov/~dms/supplmnt.html. __________________________________________________

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