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
» Consumer Health Information
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 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 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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Food Recall:
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.] 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.
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:
http://www.fda.gov/consumer/updates/albuterol053008.html
http://www.fda.gov/consumer/updates/sentinel052208.html For the latest in consumer health news from FDA, visit http://www.fda.gov/consumer/default.htm.
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