Updates : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 30 May 2008 06:06:38 -0500 (CDT)
Subject: CDRH New Update
 | Date: May 30, 2008 |
The following new items were added to the CDRH web pages on May 29, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters |  |  |
| Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System | | |
| Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin | | |
| Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions | | |
| Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications | | |
Updates: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 30 May 2008 09:04:19 -0500 (CDT)
Subject: Good Clinical Practice May 2008 Update
You are a subscriber to the Good Clinical Practice/ Human Subject Protection e-mail update service provided by the U.S. Food & Drug Administration (FDA). As such, you are receiving this message.
________________________________________________________________________________________________________________________________
Dear Subscribers,
Although somewhat dated, I thought you might be interested in knowing about the proposed rule on medical device data systems that was published in the Federal Register in February 2008. Here is a link to the FR notice:
http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-2325.htm
I also wanted to address several e-mail messages I recently received in which the senders questioned the frequency with which they might expect these messages. I usually try to bundle information so that I don't innundate you with e-mail messages. Typically I send 2 messages a month; one in the beginning and the second near the end of the month. Of course, I do send messages that contain time sensitive information on an as needed basis.
If you have any questions or suggestions about the kind of gcp/hsp related information you would like to receive, please feel free to send me your suggestions. My FDA email account is: patricia.beersblock@fda.hhs.gov
Pat Beers Block
Updates: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 30 May 2008 11:10:47 -0500 (CDT)
Subject: Transition from Chlorofluorocarbon (CFC) Propelled Albuterol Inhalers to Hydrofluroalkane (HFA) Propelled Albuterol Inhalers. Overview Version.
Transition from Chlorofluorocarbon (CFC) Propelled Albuterol Inhalers to Hydrofluroalkane (HFA) Propelled Albuterol Inhalers. Overview Version.
Fri, 30 May 2008 12:00:00 -0500
As part of a multi-year phase out, chlorofluorocarbon (CFC) propelled albuterol inhalers will not be available after December 31, 2008. Healthcare professionals should transition patients to the hydrofluoralkane (HFA) propelled albuterol inhalers now. Overview Version.
Updates: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 30 May 2008 11:10:47 -0500 (CDT)
Subject: FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now
FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now
Fri, 30 May 2008 11:00:00 -0500
CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface.
Updates: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 30 May 2008 11:11:12 -0500 (CDT)
Subject: Transition from Chlorofluorocarbon (CFC) Propelled Albuterol Inhalers to Hydrofluroalkane (HFA) Propelled Albuterol Inhalers. Full Version.
Transition from Chlorofluorocarbon (CFC) Propelled Albuterol Inhalers to Hydrofluroalkane (HFA) Propelled Albuterol Inhalers. Full Version.
Fri, 30 May 2008 12:00:00 -0500
As part of a multi-year phase out, chlorofluorocarbon (CFC) propelled albuterol inhalers will not be available after December 31, 2008. Healthcare professionals should transition patients to the hydrofluoralkane (HFA) propelled albuterol inhalers now. Full Version.
Updates: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 30 May 2008 11:42:05 -0500 (CDT)
Subject: Drug Information Update- Transition from CFC to HFA Propelled Albuterol Inhalers
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.
FDA is alerting patients, caregivers, and healthcare professionals to important information about albuterol inhalers. As part of a multi-year phase out, chlorofluorocarbon (CFC) propelled albuterol inhalers will not be available after December 31, 2008. Healthcare professionals should transition patients to the hydrofluoralkane (HFA) propelled albuterol inhalers now.
There are three HFA propelled albuterol inhalers that have been approved by the FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. Also FDA-approved is Xopenex HFA Inhalation Aerosol, an HFA propelled inhaler containing levalbuterol (the active form of albuterol).
HFA propelled albuterol inhalers may taste and feel different than the CFC propelled albuterol inhalers. Notably, the force of the spray of an HFA propelled inhaler may feel softer than that of a CFC propelled inhaler. It is important to remember that it is the deep breath that you take with each puff that gets the medication into your lungs, not the force of the spray. It is important to prime and clean the HFA propelled inhalers to prevent blockage in the inhaler device that will prevent the medicine from reaching the lungs. Each HFA propelled inhaler has different priming, cleaning, and drying instructions. Therefore, it is important to read and understand the instructions that come with each of the HFA propelled albuterol inhalers before using.
The labeling and instructions for the inhalers may be accessed at: http://dailymed.nlm.nih.gov/dailymed/about.cfm
The national transition from CFC propelled to HFA propelled albuterol inhalers is due to an international environmental treaty called the Montreal Protocol on Substances that Deplete the Ozone Layer. Under this treaty, the United States has agreed to phase out production and importation of Ozone Depleting Substances (ODS) including CFCs. Several CFC propelled inhalers containing other medicines have already been phased out. Over the next several years, other CFC propelled inhalers will be phased out.
If after following the instructions that come with each of the HFA propelled albuterol inhalers you feel the product is not effective or causing you to experience side effects we urge you to report to FDA's MedWatch program. MedWatch is a voluntary system of reporting to FDA any adverse effects and/or product problems. You can find a link to the Internet voluntary reporting form by going to the MedWatch homepage (http://www.fda.gov/medwatch/index.html), click on "How to Report", then "Reporting by Health Professionals" or "Reporting by Consumers".
You can find more information at http://www.fda.gov/cder/mdi/albuterol.htm
Updates: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 30 May 2008 12:04:11 -0500 (CDT)
Subject: Contaminated Nipple Cream
Contaminated Nipple Cream
Fri, 30 May 2008 11:27:00 -0500
FDA is warning nursing mothers not to buy or use Mommy's Bliss Nipple Cream because it contains potentially harmful ingredients.
Updates: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 30 May 2008 12:04:22 -0500 (CDT)
Subject: Albuterol Inhalers: Time to Transition
Albuterol Inhalers: Time to Transition
Fri, 30 May 2008 11:27:00 -0500
Manufacturers have been directed to phase out albuterol inhalers that use chlorofluorocarbons (CFCs)--propellants that deplete the ozone layer. Here are facts about switching to alternative inhalers that use hydrofluoroalkane (HFA) propellants.
Updates: 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 30 May 2008 13:32:52 -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.
Guidance for Industry: Indexing Structured Product Labeling (PDF - 60 KB) - 5/30/2008
Updates: 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 30 May 2008 15:09:03 -0500 (CDT)
Subject: CDER New 5/29/2008
May 29, 2008
Updates: 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 30 May 2008 16:15:29 -0500 (CDT)
Subject: Important Information about Albuterol Metered Dose Inhalers (MDIs)
Important Information about Albuterol Metered Dose Inhalers (MDIs)
Fri, 30 May 2008 15:15:00 -0500
After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information)
Updates: 12
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 30 May 2008 11:24:03 -0500 (CDT)
Subject: FDA MedWatch-Viril-ity Power (VIP) Tablets: Recall Of Supplement Product Because It Contains A Potentially Harmful Undeclared Ingredient
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International Pharmaceuticals, Ltd. and FDA notified consumers and healthcare professionals that the company is recalling all supplement products sold under the brand name of Viril-ity Power (VIP) Tablets. The product is being recalled because one lot was found to contain a potentially harmful undeclared ingredient, hydroxyhomosildenafil, an analog of sildenafil. Sildenafil is the active ingredient in Viagra, an FDA-approved drug used for erectile dysfunction. The undeclared ingredient may interact with nitrates found in some prescription drugs ( such as Nitroglycerin) and may lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates. Consumers who have Viril-ity Power (VIP) Tablets should stop using it immediately and contact their healthcare professional if they experience any problems that may be related to taking this product.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#VIP
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