FDA News Digest
July 15, 2008
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IN THIS WEEK'S ISSUE
» News
» Consumer Health Information
New Type of Genetic Test Approved for Breast Cancer Patients
FDA has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab). The SPOT-Light HER2 CISH test kit measures the number of copies of the HER2 gene in tumor tissue. This gene regulates the growth of cancer cells. FDA Requests Stronger Warnings on Fluoroquinolone Antimicrobial Drugs FDA has notified makers of fluoroquinolone antimicrobial drugs that a "boxed warning" in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary and a guide must be made available to patients that explains possible side effects. Fluoroquinolones are approved to treat or prevent certain bacterial infections.
FDA Revises Process for Responding to Drug Applications FDA is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. The agency will no longer issue "approvable" or "not approvable" letters when a drug application is not approved. Instead, it will issue a "complete response" letter that lets a company know the review period for a drug is complete and that the application is not yet ready for approval. The letter will describe deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval.
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
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
Sept. 8-10 -- Parenteral Drug Association (PDA)/FDA Joint Regulatory Conference
Location: Washington, D.C.
Sept. 10-12 -- Parenteral Drug Association (PDA)/FDA Pharmaceutical Ingredient Supply Chain Conference
Location: Washington, D.C.
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 updates in the spotlight this week are:
http://www.fda.gov/consumer/updates/hurricane052307.html
http://www.fda.gov/consumer/updates/wrinklefillers062608.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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