Update: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 15 Jul 2008 03:59:17 -0500 (CDT)
Subject: CDER New 7/14/2008
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July 14, 2008
- Genentech informs healthcare professionals of reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving Avastin in combination with sunitinib malate. MedWatch Safety Information
- Guidance for Industry: Current Good Manufacturing Practice for Phase 1 Investigational Drugs [PDF]
- New and Generic Drug Approvals
- Avandia (rosiglitazone maleate) Tablets, GlaxoSmithKline, Efficacy Supplement with Clinical Data to Support
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 15 Jul 2008 05:36:06 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: July 15, 2008 |
The following new items were added to the CDRH web pages on July 14, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | FDA Preliminary Public Health Notification: Possible Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT) Scanning |  |
| Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, July 15, 2008 - Agenda, Roster, Briefing, Questions | |
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 15 Jul 2008 10:13:29 -0500 (CDT)
Subject: FDA Data Standards Update - SPL Release Four Training Sessions
Greetings,
The FDA Data Standards Council's website was updated on Tuesday, July 15, 2008, to include a web page (http://www.fda.gov/oc/datacouncil/spl_rel_four_training_sessions_july_08.html) announcing SPL Release Four Training Sessions.
Lonnie Smith
Project Manager
Structured Product Labeling Team
Medical Informatics Staff &
FDA Data Standards Council
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 15 Jul 2008 14:18:49 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Proposed and Final Rules Update
You are subscribed to CBER's Proposed and Final Rules for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials; Final Rule
Posted: 7/15/2008
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 15 Jul 2008 16:06:01 -0500 (CDT)
Subject: FDA News Digest for July 15, 2008
FDA News Digest
July 15, 2008
_____________________________________
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. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01858.html 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.]
_____________________________________________
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.
Comments about FDA News Digest?
Send an e-mail to fdanewsdigest@oc.fda.gov.
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 15 Jul 2008 18:02:27 -0500 (CDT)
Subject: Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14)
Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14)
Tue, 15 Jul 2008 16:53:00 -0500
Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010).
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