FDA News Digest for June 25, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

June 25, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- 'EMMA' Cleared; Allows Remote Release of Prescription Drugs

    -- New Drug Lyrica Helps Treat Some Patients With Fibromyalgia

    -- Rule Finalized to Help Ensure Dietary Supplement Quality

    -- Shelhigh Agrees to Stop Device Distribution Pending Problem Fixes

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

'EMMA' Cleared; Allows Remote Release of Prescription Drugs

FDA has cleared for marketing the Electronic Medication Management Assistant (EMMA), a device that allows health professionals to remotely manage prescription medicine that is stored and released by a patient-operated delivery system. EMMA can help reduce drug identification and dosing errors, and it provides a monitor for patient adherence to drug regimens.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01655.html

 

New Drug Lyrica Helps Treat Some Patients With Fibromyalgia

FDA has approved Lyrica (pregabalin), the first drug to treat fibromyalgia, a disorder characterized by pain, fatigue, and sleep problems. The drug was shown in clinical trials to reduce pain and improve daily functions for some fibromyalgia patients.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01656.html

 

Rule Finalized to Help Ensure Dietary Supplement Quality

FDA has issued a final rule establishing requirements to ensure that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled. The rule also includes requirements for recordkeeping and for handling consumer complaints.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01657.html

-- Backgrounder: http://www.cfsan.fda.gov/~dms/dscgmps7.html

-- Fact sheet: http://www.cfsan.fda.gov/~dms/dscgmps6.html

 

Shelhigh Agrees to Stop Device Distribution Pending Problem Fixes

New Jersey implantable medical device company Shelhigh Inc. has agreed to stop distributing its products until the company's production processes comply with FDA manufacturing and quality regulations. Among Shelhigh's products are pediatric heart valves, surgical patches, and arterial grafts.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01658.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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UPCOMING PUBLIC MEETINGS

June 27 -- Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

    Under discussion: oncology products granted pediatric exclusivity under the Best Pharmaceuticals for Children Act

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-8656.htm

 

June 27 -- Circulatory System Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for a medical device that treats atrial flutter

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-9054.htm

 

July 17 -- Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for cervical disc prosthesis

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-10267.htm

 

For a complete list of FDA meetings, seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html.

 

 

 

QUESTION OF THE WEEK

 

What are counterfeit drugs?

Counterfeit drugs are those sold under a product name without proper authorization. Counterfeiting can apply to both brand name and generic products, where the identity of the source is deliberately and fraudulently mislabeled in a way that suggests that it is an authentic approved product. Counterfeit products may include products without the active ingredient, with an insufficient quantity of the active ingredient, with the wrong active ingredient, or with fake packaging.

 

Taking a counterfeit medication may put you at risk for a number of dangerous health consequences. You may experience unexpected side effects, allergic reactions, or a worsening of your medical condition. Some counterfeits may not contain any active ingredients and instead may contain inert substances, which do not provide any treatment benefit. Counterfeit medications may also contain incorrect ingredients, improper dosages of the correct ingredients, or hazardous ingredients.

 

For more on counterfeit drugs, see http://www.fda.gov/oc/initiatives/counterfeit/default.htm.

 

 

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