From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 21 May 2008 06:26:47 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Guidances Update
You are subscribed to CBER's Guidances for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Draft Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products - 5/21/2008
Updates: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 21 May 2008 07:51:44 -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: May 21, 2008 |
The following new items were added to the CDRH web pages on May 20, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | FDA Workshop: Exploration of Public Policy Development Regarding the Study and Analysis of Sex Differences in the Clinical Evaluation of Cardiovascular Medical Products, June 2, 2008 |  | |
| Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays; Availability. | |  |
| Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Plasmodium Species Antigen Detection Assays. | | |
Updates: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 21 May 2008 08:36:39 -0500 (CDT)
Subject: FDA Warning Letters Update
You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Updates: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 21 May 2008 10:47:22 -0500 (CDT)
Subject: Maturity Health Matters Update
You are subscribed to Maturity Health Matters from the U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
The main article of Issue 8 (Spring 2008), "Healthy Weight -- What It Means to You", points out that approximately 71 percent of Americans over 50 are either overweight or obese. A Body Mass Index (BMI) chart is provided for all to check their status. Another article discusses LASIK designed for treating one eye for near vision and the other for far vision: Monovision. Other articles discuss buying drugs online, generic drug improvement, denture cleansers, x-ray savvy, food safety efforts, and FDA's new Home Page. A new feature has been added called "Recent News from FDA." This page will continue to list new FDA product approvals, recalls, and Public Health Advisories.
Updates: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 21 May 2008 14:54:08 -0500 (CDT)
Subject: CDER New 5/21/2008
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May 21, 2008
- Drugs@FDA Downloadable Data Files (updated)
- FDA approves Entereg (alvimopan) to help restore bowel function following surgery. FDA News
- New and Generic Drug Approvals
- Promethazine Hydrochloride Tablets, Impax Laboratories, Inc., Approval
- Ropinirole Hydrochloride Tablets, Corepharma, LLC, Approval
- Venlafaxine Hydrochloride Extended-Release Tablets, Osmotica Pharmaceutical Corp., Approval
Updates: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 21 May 2008 16:10:26 -0500 (CDT)
Subject: Enforcement Report for May 21, 2008
Enforcement Report for May 21, 2008
Wed, 21 May 2008 14:31:00 -0500
Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
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