FDA News Digest for October 1, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

October 1, 2007

__________________________________________

 

IN THIS WEEK'S ISSUE

 

»  News

    --  Afluria Approved as an Additional Vaccine for Upcoming Flu Season

    --  FDA Taking Action on Unapproved Cough Suppressants With Hydrocodone

    --  Oral Granules Approved to Treat Fungal Scalp Infection in Children

    --  FDA Amendments Act Gives Agency Renewed Resources for Regulation

    --  'FDA Patient Safety News' Video Available Online and as Podcast

»  Congressional Testimony

»  Upcoming Public Meetings

»  Consumer Health Information

__________________________________________

NEWS

 

Afluria Approved as an Additional Vaccine for Upcoming Flu Season

FDA has approved Afluria, an additional seasonal vaccine for immunizing adults against type A and B flu viruses. The approval brings to six the number of seasonal flu vaccine makers licensed for the U.S. market. Together, the companies will provide a total of 132 million doses of flu vaccine for the 2007-2008 flu season.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01714.html

 

FDA Taking Action on Unapproved Cough Suppressants With Hydrocodone

FDA plans to take enforcement action against companies that market unapproved prescription drugs containing hydrocodone, a narcotic widely used to treat pain and suppress coughs. The agency is concerned about the improper labeling for children of these unapproved drugs and the risk of medication errors. The action does not affect approved drugs with hydrocodone.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01713.html

 

Oral Granules Approved to Treat Fungal Scalp Infection in Children

FDA has approved Lamisil Oral Granules for the treatment of tinea capitis, a fungal infection of the scalp, in children aged 4 years and older. The medicine is intended to be sprinkled on food. Tinea capitis, also called ringworm of the scalp, is a persistent and contagious infection often characterized by severe itching, dandruff, and bald patches.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01715.html

 

FDA Amendments Act Gives Agency Renewed Resources for Regulation

On Sept. 27, President Bush signed the Food and Drug Administration Amendments Act into law, ensuring that the agency has the additional resources needed to conduct the comprehensive reviews necessary for new drugs and medical devices.

http://www.hhs.gov/news/press/2007pres/09/pr20070927e.html

 

'FDA Patient Safety News' Video Available Online and as Podcast

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 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.]

___________________________________________

 

CONGRESSIONAL TESTIMONY

 

Sept. 26 -- FDA Deputy Commissioner for Policy Randall Lutter, Ph.D., appeared before the House Subcommittee on Health

    Subject: "Regulation of Imported FDA-Regulated Products"

http://www.fda.gov/ola/2007/import092607.html

 

To view an archive of past testimony by FDA officials, go to

http://www.fda.gov/ola/listing.html

   

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

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

_________________________________________________

 

UPCOMING PUBLIC MEETINGS

 

Oct. 19 -- Information Technology Strategic Planning

    Under discussion: how the agency can best use information technology resources to support drug reviews

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/07-4692.htm

 

 

CONSUMER HEALTH INFORMATION

 

FDA's Web site features a page with information for consumers. Each week in FDA News Digest, we will spotlight material from that page by offering links to timely articles about FDA activities and products the agency regulates.

 

Here's what's in the spotlight this week:

 

›   Managing Drug Safety Issues: Q & A with Paul Seligman, M.D.

http://www.fda.gov/consumer/updates/drugsafetyqa053107.html

›  The Possible Dangers of Buying Medicine Online

http://www.fda.gov/consumer/features/drugsonline0707.html

›  FDA 101 Infant Formula

http://www.fda.gov/consumer/updates/infantformula080607.html

 

FDA offers a free e-newsletter for consumers that contains information posted on the consumer health Web page. To subscribe, go to http://www.fda.gov/consumer/consumerenews.html.

 

For those who are members of the press or who manage Web sites, we encourage you to link to this information or incorporate it into your online or printed publications. (We'd appreciate a credit to "FDA Consumer Health Information.")

Questions or comments about our consumer stories or the consumer health e-newsletter? Send an e-mail to fdaconsumerlist@xxxxxxxxxx.  

 

 

Thanks for subscribing to FDA News Digest.

Our next issue will be sent October 9.

 

Comments about FDA News Digest?

Send an e-mail to fdanewsdigest@xxxxxxxxxv.

 

To subscribe to or unsubscribe from this list, go to

http://list.nih.gov/cgi-bin/wa?SUBED1=fda-newsdigest-l&A=1.