FDA News
Digest
November 8,
2004
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IN THIS WEEK'S ISSUE
-- Measures Announced to Bolster Safety Evaluations for Drugs
-- 'Roadmap' for Regulating Dietary Supplements Unveiled
-- Avoid 'Actra-Rx,' 'Yilishen,' Promoted for Sexual Enhancement
-- FDA Completes Its Review of Reprocessed Single-Use Devices
-- FDA Guidance Details Changes to Generic Drug Approval Process
-- Recalls/Market Withdrawals
-- Public Meetings
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Measures Announced to Bolster Safety Evaluations for Drugs
FDA has announced a series of steps aimed at strengthening the agency's program for evaluating the safety of marketed drugs. Among measures: a study of the national drug safety system by the Institute of Medicine; a program for mediating differing opinions among product reviewers; and workshops and meetings to discuss complex drug safety and risk management issues.
'Roadmap' for Regulating Dietary Supplements Unveiled
FDA has unveiled three initiatives intended to further implement 1994 dietary supplement legislation. These include a regulatory strategy to help evaluate safety concerns about dietary ingredients and dietary supplements, an open public meeting to explain the notification process for new dietary ingredients, and a draft guidance for industry that clarifies what is needed to substantiate health claims.
Press release: http://www.fda.gov/bbs/topics/news/2004/NEW01130.html
Regulatory strategy document: http://www.cfsan.fda.gov/~dms/ds3strat.html
Draft industry guidance: http://www.cfsan.fda.gov/~dms/dsclmgui.html
Avoid 'Actra-Rx,' 'Yilishen,' Promoted for Sexual Enhancement
FDA is warning consumers not to buy or use Actra-Rx or Yilishen, two products promoted and sold online for treating erectile dysfunction and enhancing sexual performance for men. Consumers using the products risk serious, possibly life-threatening, adverse effects. Though marketed as "dietary supplements," the products were found to contain an active prescription drug ingredient.
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01322.html
FDA Completes Its Review of Reprocessed Single-Use Devices
FDA has completed reviewing data submissions to determine if certain medical devices intended for single use can remain on the market. The agency reviewed 44 data submissions -- each of which may cover from one to several hundred device models -- and ruled that devices represented by 11 submissions must be withdrawn.
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01323.html
FDA Guidance Details Changes to
Generic Drug Approval Process
FDA has issued guidance for industry that explains some of the steps the agency is taking to implement revisions to the generic drug approval process that are part of the recent Medicare prescription drug law. The guidance clarifies, for example, the 180-day marketing exclusivity for "first" generic drug applicants.
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01324.html
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RECALLS, MARKET WITHDRAWALS
The following products are being recalled for the reasons shown. Go to the linked page for more information.
Halloween Sour Kids Jelly Candy Pops (undeclared egg)
http://www.fda.gov/oc/po/firmrecalls/morris11_04.html
Schwan's Breaded
Haddock Squares and Sticks (undeclared whey)
http://www.fda.gov/oc/po/firmrecalls/iceland11_04.html
For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the last 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.
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PUBLIC MEETINGS
Nov. 15 -- Meeting to solicit comments on FDA's premarket notification program for new dietary ingredients; College Park, Md.
http://www.cfsan.fda.gov/~dms/ds-ndi.html
Nov. 18 -- Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002; Gaithersburg, Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-21676.htm
For a list of FDA meeting, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html.
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