FDA News -- FDA News Digest for June 2, 2008

FDA News Digest

June 2, 2008

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IN THIS WEEK'S ISSUE

» News

-- Labeling Changes Proposed for Rx Drugs Used During Pregnancy, Breastfeeding

-- 'FDA Patient Safety News' Video, Podcast Available

» Safety Alerts/Recalls

» Upcoming Public Meetings

» Consumer Health Information

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NEWS

Labeling Changes Proposed for Rx Drugs Used During Pregnancy, Breastfeeding

FDA has proposed major revisions to physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breastfeeding. The changes would give health care professionals more comprehensive information for making prescribing decisions and for counseling women about using prescription medications if they are pregnant, breastfeeding, or of childbearing age.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01841.html

'FDA Patient Safety News' Video, Podcast Available

FDA has posted the latest edition of "FDA Patient Safety News," a free Web-based video news program. Aimed primarily at health professionals, the program features information on new drugs, biologics, and medical devices, as well as FDA safety notifications and product recalls.

-- To view video or text version: http://www.fda.gov/psn

-- To access Podcast: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/podcast.cfm

To view an archive of recent 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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SAFETY ALERTS/RECALLS

Food Recall:

› Certain lots of Amish Macaroni Salad under the Orval Kent or Yoder's label (various sizes)

Reason for recall: a precaution due to results of tests on a single package for E. coli O157:H7

http://www.fda.gov/oc/po/firmrecalls/orvalkent05_08.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

June 9 -- Pediatric Ethics Subcommittee of the Pediatric Advisory Committee

Under discussion: regulations applying to clinical investigations involving greater than minimal risk but presenting possible direct patient benefit

Location: Gaithersburg, Md.

http://edocket.access.gpo.gov/2008/E8-8352.htm

June 10 -- Ophthalmic Devices Panel of the Medical Devices Advisory Committee

Under discussion: postmarket experience with various contact lens care products

Location: Gaithersburg, Md.

http://edocket.access.gpo.gov/2008/E8-11451.htm

June 12 -- Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee

Under discussion: pending application to market a surgical sealant

Location: Gaithersburg, md.

http://edocket.access.gpo.gov/2008/E8-9537.htm

For a complete list of upcoming meetings, seminars, and other public events sponsored

or co-sponsored by FDA, go to http://www.fda.gov/opacom/hpmeetings.html.

CONSUMER HEALTH INFORMATION

Note to readers: In this space last week, we included a link to a consumer health article called "Start at the Store: 7 Ways to Prevent Foodborne Illness." Unfortunately, there was a character missing in the link that caused an error message. We'd like to give you the correct link this week so you can view this important article. The link is: http://www.fda.gov/consumer/updates/foodillness051308.html.

Other consumer updates in the spotlight this week are:

› Albuterol Inhalers: Time to Transition

http://www.fda.gov/consumer/updates/albuterol053008.html

› Sentinel System to Monitor Medical Product Safety

http://www.fda.gov/consumer/updates/sentinel052208.html

To receive all consumer updates by e-mail, go to http://www.fda.gov/consumer/consumerenews.html.

For the latest in consumer health news from FDA, visit http://www.fda.gov/consumer/default.htm.

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