From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 28 May 2008 06:15:11 -0500 (CDT)
Subject: CDRH New Update
    |
| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
 | ||
 | Date: May 28, 2008 |
The following new items were added to the CDRH web pages on May 27, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Transcripts |  | |
| Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Other | | |
| Summary Information for: Zenith® TX2®® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System |  |
Updates: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 28 May 2008 08:06:35 -0500 (CDT)
Subject: Enforcement Report for May 28, 2008
Enforcement Report for May 28, 2008
Wed, 28 May 2008 05:51:00 -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.
Updates: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 28 May 2008 08:27:02 -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, 28 May 2008 13:06:38 -0500 (CDT)
Subject: FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding
FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding
Wed, 28 May 2008 13:00:00 -0500
The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.
Updates: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 28 May 2008 14:11:38 -0500 (CDT)
Subject: Drug Information Update- FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration today proposed major revisions to the physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding.
The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.
Although physician labeling is directed to health care professionals, it is sometimes adapted for use in consumer-directed labeling such as patient package inserts or medication guides when such labeling is approved for a prescription drug.
The proposed rule outlines what important information about the use of medicines during pregnancy and breast-feeding would be required to be added to product labeling for newly approved drugs. Under the proposal, drug labeling would explain, based on available information, the potential benefits and risks for the mother and the fetus, and how these risks may change during the course of pregnancy.
The proposed rule would remove the letter categories from the pregnancy section of prescription drug labeling. The newly designed format, for the pregnancy section of the labeling would have three sections:
- The first section, called the "Fetal Risk Summary," would describe what is known about the effects of the drug on the fetus, and if there is a risk, whether this risk is based on information from animals or humans. The proposal calls for a risk conclusion based on the available data and provides a number of examples depending on the quality and quantity of that data. For example, one risk conclusion might be: "Human data indicate that (name of drug) increases the risk of cardiac abnormalities." This would be followed by a summary of the most important data on the drug’s effects.
- Another section, called "Clinical Considerations," would include information about the effects of the use of the drug if it is taken before a woman knows she is pregnant. This section also would feature discussions about the risks of the disease to the mother and the baby, dosing information, and tell how to address complications.
- The third section, under the heading "Data," would describe in more detail the available data regarding use of the drug in humans and from animal studies that were used to develop the Fetal Risk Summary.
The pregnancy section would also include information about whether there is a pregnancy exposure registry for the drug. Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women.
The lactation (breastfeeding) section of prescription drug labeling would use the same format as the pregnancy section. The lactation section would provide information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.
Certain newly approved drugs would use the new pregnancy and lactation labeling format, while labeling for previously approved drugs will be phased in gradually under FDA’s recent Physician Labeling Rulemaking.
Electronic comments can be submitted within 90 days via the Federal Documents Management System/eRulemaking portal at www.regulations.gov. The FDA will carefully consider the comments in preparing a final rule.
For more information, visit: http://www.fda.gov/cder/regulatory/pregnancy_labeling/default.htm
Updates: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 28 May 2008 15:04:54 -0500 (CDT)
Subject: FDA Takes Action Against Scientific Laboratories Inc.
FDA Takes Action Against Scientific Laboratories Inc.
Wed, 28 May 2008 14:06:00 -0500
A permanent injunction bars Scientific Laboratories from making and distributing drug products until its manufacturing operations comply with law and its products are approved.
Updates: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 28 May 2008 15:05:08 -0500 (CDT)
Subject: Enforcement Actions for Food Safety Violations
Enforcement Actions for Food Safety Violations
Wed, 28 May 2008 14:06:00 -0500
In separate enforcement actions, FDA shuts down companies for food safety violations. These actions include a recall of certain smoked seafood products.
Updates: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 28 May 2008 15:05:15 -0500 (CDT)
Subject: Pregnant Women to Benefit from Better Information
Pregnant Women to Benefit from Better Information
Wed, 28 May 2008 14:06:00 -0500
A proposed rule will give women and their health care professionals better information concerning the effects of medications taken during pregnancy or while breastfeeding.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
