FDA News Digest

June 2, 2008 ___________________________________

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 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

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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