22 janvier, 2007 17:22

FDA News Digest for January 22, 2007

-- FDA Commissioner Announces High-Level Agency Changes

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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.

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.

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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

Food Recall:

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

Reason for recall: undeclared sulfites

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

Under discussion: oral and non-oral hormonal contraceptives

Location: Rockville, Md.

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.

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

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

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

Location: Dallas

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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.

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