FDA News Digest for April 24, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest     

April 24, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- Electronic Labeling Initiative Adopted for Prescription Drugs

    -- Officers of Florida Company Convicted in Blood Diversion Scheme

    -- First Director of Drug Safety Policy and Communication Named

»  Recalls/Safety Alerts

»  Recent Speeches

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

Electronic Labeling Initiative Adopted for Prescription Drugs

FDA has adopted the Systematized Nomenclature of Medicine (SNOMED), an initiative that will allow healthcare professionals to share critical health and treatment information electronically. SNOMED will advance the effort to create electronic health records for Americans within the next decade.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01361.html

 

Officers of Florida Company Convicted in Blood Diversion Scheme

Two officers in Florida-based Bio-Med Plus have been convicted in a Georgia district court of more than 247 criminal counts stemming from an illegal medical products diversion scheme that defrauded the federal Medicare and Medicaid programs of more than $45 million. FDA's Office of Criminal Investigations conducted investigations in the case.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01360.html

 

First Director of Drug Safety Policy and Communication Named

FDA has appointed Paul Seligman, M.D., its first associate center director for safety policy and communication within the agency's Center for Drug Evaluation and Research. He will oversee drug safety issues and policies and manage the distribution of drug safety information to healthcare professionals.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01359.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

Device Recall:

 

Two lots of VITROS Immunodiagnostic Products Signal Reagent (a chemical used in health screening tests)

    Reason for recall: could produce inaccurate results

http://www.fda.gov/cdrh/recalls/recall-032806.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

 

April 7 -- FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke at the Annual Generic Drug Forum.

    Subject: generic drug approvals

http://www.fda.gov/oc/speeches/2006/genericdrug0407.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 25 -- Small Pharmaceutical Business Educational Forum

    Under discussion: FDA's pre-market 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

 

April 28 -- Risk Management, Corrective and Preventive Actions, and Training: An Educational Forum

    Under discussion: FDA's quality systems regulation (especially of interest to small businesses)

    Location: Dallas

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-23677.htm

 

May 17 -- Peripheral and Central Nervous System Drugs Advisory Committee

    Under discussion: a proposed treatment for dementia associated with Parkinson's disease

    Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2006/cder12543d051706.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 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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