U.S. Food & Drug Administration (FDA) Weekly Digest Bulletin

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If you have an extra couple hours to read though this, you may find it interesting . .. It's worth scanning anyway ...New methods received PMA (PreMarket Approval) for making breast implants!Rogene-----------------------------------------------------From: "U.S. Food & Drug Administration (FDA)" <fda@...>

Date: Mon, 14 Apr 2008 11:07:46 -0500 (CDT)

Subject: Private Selection Ice Cream Recalled From Kroger Stores In Twelve Southeastern States (April 7)

Private Selection Ice Cream Recalled From Kroger Stores In Twelve Southeastern States (April 7)Mon, 14 Apr 2008 10:50:00 -0500Inter-American Products, Inc., a division of The Kroger Co., today announced a recall on two codes of Private Selection Light Churned Mint Chocolate Chip Ice Cream in 1.75-quart containers with a "Sell By" date of December 3, 2008. The two codes are: DEC0308 8070 and DEC0308 8080.

Message: 2

From: "U.S. Food & Drug Administration (FDA)" <fda@...>

Date: Mon, 14 Apr 2008 16:05:50 -0500 (CDT)

Subject: Salmonella Illnesses May be Linked to Recalled Cereal

Salmonella Illnesses May be Linked to Recalled CerealMon, 14 Apr 2008 14:10:00 -0500At least 23 people in 14 states have been diagnosed with salmonellosis that was caused by the same strain of Salmonella found in the recently recalled unsweetened Puffed Rice and unsweetened Puffed Wheat Cereals produced by Malt-O-Meal

Message: 3

From: "U.S. Food & Drug Administration (FDA)" <fda@...>

Date: Mon, 14 Apr 2008 16:09:34 -0500 (CDT)

Subject: FDA News Digest

FDA News Digest

April 14, 2008

_____________________________________

IN THIS WEEK'S ISSUE

» News

-- More Than $100,000 of Unapproved Drugs Marketed as 'Natural Supplements' Seized

» Safety Alerts/Recalls » Upcoming Public Meetings » Consumer Health Information

__________________________________________

NEWS

More Than $100,000 of Unapproved Drugs Marketed as 'Natural Supplements' Seized

At FDA's request, U.S. marshals have seized more than 14,000 dosage units of Shangai Regular, Shangai Ultra, Super Shangai, Naturalë Super Plus, and Lady Shangai. Although labeled as natural supplements, the seized products were all marketed to treat erectile dysfunction (ED), impotency, or to provide sexual enhancement, which caused them to be drugs under federal law. The seized products, valued at more than $100,000, contain undeclared active ingredients found in FDA-approved prescription drugs for ED, or similar substances. Use of these products may result in serious side effects and may

interact in dangerous ways with medications that consumers already may be taking.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01817.html

To view an archive of recent FDA news releases, go to

http://www.fda.gov/opacom/hpnews.html. 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

Safety Alert:

› FDA has announced that at least 23 people in 14 states have been diagnosed with salmonellosis caused by the same strain of Salmonella found in the recently recalled unsweetened Puffed Rice and unsweetened Puffed Wheat Cereals produced by Malt-O-Meal. The recalled products were distributed nationally under the Malt-O-Meal brand name as well as under private-label brands including Acme ,

America 's Choice, Food Club, Giant, Hannaford, Jewel, Lynn, Pathmark, Shaw's, ShopRite, Tops and Weis Quality. The cereals have "Best If Used By" dates from April 8, 2008 (coded as "APR0808") through March 18, 2009 (coded as "MAR1809"). Consumers should throw out any product in their homes from these recalled lots.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01819.html

Food Recall:

› Cracker Barrel Chocolate-Covered Almonds and Chocolate Double-Dipped Peanuts; 5-oz. bags

Reason for recall: packaging is mislabeled

http://www.fda.gov/oc/po/firmrecalls/crackerbarrel04_08.html

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

April 16 -- Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

Under discussion: opportunities for enhancing global pediatric oncology drug development

Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-3676.htm

April 24-25 -- Ophthalmic Devices Panel of the Medical Devices Advisory Committee

Under discussion: pending application to market an implantable miniature telescope Location: Gaithersburg, Md. http://edocket.access.gpo.gov/2008/E8-5810.htm

April 29-30 -- Public Workshop on Safety of Hemoglobin-Based Oxygen rs Location: Bethesda, Md. http://www.fda.gov/cber/meetings/hboc042908.htm

For a complete list of meetings, seminars, and other public events sponsored or co-sponsored by FDA, go to http://www.fda.gov/opacom/hpmeetings.html.

CONSUMER HEALTH INFORMATION Each week, we offer links to articles about FDA activities and FDA-regulated products. In the spotlight this week:

› Use Caution with Over-the-Counter Creams, Ointments http://www.fda.gov/consumer/updates/otc_creams040108.html

› Warning About “Total Body” Liquid Supplements http://www.fda.gov/consumer/updates/totalbody040108.html

To receive all consumer updates, go to http://www.fda.gov/consumer/consumerenews.html

Thanks for subscribing to FDA News Digest.

Our next issue will be sent April 21. Comments about FDA News Digest?

Send an e-mail to fdanewsdigest@...v.

Message: 4

From: "U.S. Food & Drug Administration (FDA)" <fda@...>

Date: Wed, 16 Apr 2008 05:49:33 -0500 (CDT)

Subject: CDRH New Update

FDA Home Page | CDRH Home Page | Search | A-Z Index Date: April 16, 2008 The following new items were added to the CDRH web pages on April 15, 2008. Previous CDRH New Items can be found on the CDRHNew Page. PMA Final Decisions for March 2008

Message: 5

From: "U.S. Food & Drug Administration (FDA)" <fda@...>

Date: Wed, 16 Apr 2008 09:55:48 -0500 (CDT)

Subject: CDER New

April 15, 2008

New and Generic Drug Approvals

Cleocin Phosphate (clindamycin phosphate) Injection, Pfizer, Labeling Revision

Cleocin Phosphate in Dextrose 5% in Plastic Container (clindamycin phosphate) I.V. Sterile Solution, Pfizer, Labeling Revision

Evamist (estradiol) Transdermal Spray, KV Pharma, Labeling Revision

Luvox (fluvoxamine maleate) Tablets, Jazz Pharma, Approval

PULMICORT FLEXHALER (budesonide) Inhalation Powder, AstraZeneca, Labeling Revision

Trelstar Depot (triptorelin pamoate) Injectable; Intramuscular, Labs, Control Supplement

Trelstar LA (triptorelin pamoate) Injectable; Intramuscular, Labs, Control Supplement

Unasyn (ampicillin sodium, sulbactam sodium) Injection, Pfizer, Labeling Revision

Zerit (stavudine) Capsules, Bristol-Myers Squibb, Labeling Revision

Zerit (stavudine) For Oral Solution, Bristol-Myers Squibb, Control Supplement

Zerit (stavudine) For Oral Solution, Bristol-Myers Squibb, Labeling Revision

Paragraph IV Patent Certifications (updated)

Message: 6

From: "U.S. Food & Drug Administration (FDA)" <fda@...>

Date: Wed, 16 Apr 2008 12:06:09 -0500 (CDT)

Subject: Grand Carnival L.L.C Issues Allergy Alert on Undeclared Milk in its "S'morestick Kit" (April 16)

Grand Carnival L.L.C Issues Allergy Alert on Undeclared Milk in its "S'morestick Kit" (April 16)Thu, 17 Apr 2008 11:44:00 -0500The recalled "S'morestick Kits" were in limited distribution to Garden Ridge retail stores located in TX, KY, MO, TN, OK, NC, FL, SC, GA, IL, OH, VA, AR, MI, and IN, and bear the "Use

By" date of "2/14/09". The "S'morestick Kit" is packaged in a clear plastic tube containing individual clear plastic packages of marshmallows, graham crackers, and chocolate pieces. S'morestick Kits subject to this recall do NOT have a "contains milk" statement following the ingredient statement affixed to the clear plastic tube. There is no health risk for consumers who are not allergic to milk.

Message: 7

From: "U.S. Food & Drug Administration (FDA)" <fda@...>

Date: Wed, 16 Apr 2008 12:24:55 -0500 (CDT)

Subject: CFSAN Constituent Update April 16, 2008

* U.S. Food and Drug Administration *

* Center for Food Safety and Applied Nutrition *

CONSTITUENT UPDATE

Constituent Updates are also available on the web at http://www.cfsan.fda.gov/~dms/cfsupdat.html.

April 16, 2008 Listeria Monocytogenes Guidance Documents FDA recently announced the availability for public comment of two draft guidance documents regarding Listeria monocytogenes (73 FR 7293; February 7, 2008). One document is entitled "Compliance Policy Guide Sec. 555.320 Listeria monocytogenes" (the draft CPG) (Docket No. FDA-2008-D-0058). The second document is entitled "Guidance for Industry: Control of Listeria monocytogenes in

Refrigerated or Frozen Ready-To-Eat Foods" (the draft Guidance for Industry) (originally Docket No. 2007D-0474; now Docket FDA-2008-D-0096). We also announced a public meeting, to be held on March 28, 2008, to discuss the draft CPG (73 FR 7298; February 7, 2008). When we announced the availability of the draft guidance documents and of the public meeting, we requested comment on the two draft documents. Although you may comment on any FDA guidance document at any time (see 21 CFR 10.115(g)(5)), the Notice of Availability (NOA) for FDA’s draft Compliance Policy Guide on Listeria monocytogenes requested that written or electronic comments on the draft guidance be submitted by April 7, 2008 (the NOA date) (73 FR 7293; February 7, 2008). In that NOA, we advised that written comments should be submitted to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and that electronic

comments should be submitted to http://www.regulations.gov. At the March 28, 2008, FDA public meeting, we noted that we do not expect to finalize the draft CPG until there has been a reasonable time for the public to access the transcript, and emphasized that comments on a FDA guidance document may be submitted at any time, including after the date identified in the corresponding NOA. Given the relationship between the draft CPG and the draft Guidance for Industry, we would expect to finalize the Guidance for Industry after the same period of access. FDA subsequently learned that the time frame for submitting electronic comments ordinarily closes on the NOA date. After the NOA date, the customary process has been to submit comments in writing to the Division of Dockets Management at the address noted above. On April 14, 2008, FDA implemented a new process to enable stakeholders to continue to submit electronic comments on guidance documents after the NOA date. To submit comments on the draft CPG at www.regulations.gov, go to Document FDA-2008-D-0058-0005 (Compliance Policy Guide Sec. 555.320 Listeria monocytogenes - Draft Guidance) and click on the icon "Send a Comment or Submission." To submit comments on the draft Guidance to Industry at www.regulations.gov, go to Document FDA-2008-D-0096-0002 (Guidance for Industry - Control of Listeria

monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods - Draft Guidance) and click on the icon "Send a Comment or Submission." FDA apologizes for any inconvenience due to the closure of the electronic portal during April 8 – 13, 2008. Please direct any questions about this Update to .Losikoff@... or call 301-436-1412.

Message: 8

From: "U.S. Food & Drug Administration (FDA)" <fda@...>

Date: Wed, 16 Apr 2008 13:51:02 -0500 (CDT)

Subject: Drug Information Update- Review of Therapeutic Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg

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 received reports of loss of antidepressant effect and new or worsening side effects in some patients who switched from the brand name drug, Wellbutrin XL, used to treat depression, to a generic version of the drug. The FDA reviewed the safety and effectiveness of a generic version, bupropion hydrochloride extended release 300 milligram tablets, manufactured by Impax Laboratories and distributed by Teva Pharmaceuticals. The agency evaluated adverse event reports and other data in order to provide the public with current drug safety information. The FDA has completed its evaluation of Teva’s version of generic bupropion extended- release tablets, marketed as Budeprion XL 300 milligram. The FDA considers Teva’s generic drug to be a safe and effective choice for consumers in treating depression, as it has been shown to meet all requirements for approval, including bioequivalence to the branded drug, Wellbutrin XL 300 milligram. The FDA’s conclusions can be found in a review of therapeutic equivalence that was released today. Wellbutrin XL is owned by GlaxoKline, Philadelphia , and manufactured by Biovail, Mississauga , Ontario , Canada . Budeprion XL is manufactured by Impax Laboratories, Hayward , Calif. , and distributed by Teva Pharmaceuticals, North Wales, Penn. For more information, please visit: Review of Therapeutic Equivalence: Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg www.fda.gov/cder/drug/infopage/bupropion/TE_review.htm Consumer Education: Generic Drugs www.fda.gov/cder/consumerinfo/generic_text.htm

Message: 9

From: "U.S. Food & Drug Administration (FDA)" <fda@...>

Date: Wed, 16 Apr 2008 14:08:00 -0500 (CDT)

Subject: Enforcement Report for April 16, 2008

Enforcement Report for April 16, 2008Wed, 16 Apr 2008 07:00:00 -0500Weekly 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.

Message: 10

From: "U.S. Food & Drug Administration (FDA)" <fda@...>

Date: Thu, 17 Apr 2008 06:05:01 -0500 (CDT)

Subject: Pulmuone Wildwood, Inc. Issues Allergy Alert on Undeclared Eggs in Leek and Oriental Noodle Fried Dumplings (April 16)

Pulmuone Wildwood, Inc. Issues Allergy Alert on Undeclared Eggs in Leek and Oriental Noodle Fried Dumplings (April 16)Thu, 17 Apr 2008 05:44:00 -0500Pulmuone Wildwood, Inc. is recalling 1,000 cases of Leek and Oriental Noodle Fried Dumplings, because they may contain undeclared eggs. The product affected is

packaged in a white resealable 25.4 oz pouch with the UPC code 801114-306338 and the Code dates 2/2/2009, 2/9/2009 and 3/6/2009.

Message: 11

From: "U.S. Food & Drug Administration (FDA)" <fda@...>

Date: Thu, 17 Apr 2008 09:38:19 -0500 (CDT)

Subject: Recent Device Approvals: Medtronic Talent™ Abdominal Stent Graft System

You are subscribed to Recent Device Approvals updates for U.S. Food & Drug Administration (FDA). Information about Medtronic's Talent™ Abdominal Stent Graft System has recently been posted to the FDA website, and is now available.

Message: 12

From: "U.S. Food & Drug Administration (FDA)" <fda@...>

Date: Thu, 17 Apr 2008 16:05:56 -0500 (CDT)

Subject: Use Eye Cosmetics Safely

Use Eye Cosmetics SafelyThu, 17 Apr 2008 15:35:00 -0500April is Women's Eye Health and Safety Month. Here are tips from FDA about storing, applying, wearing, and removing eye cosmetics.

Message: 13

From: "U.S. Food & Drug Administration (FDA)" <fda@...>

Date: Fri, 18 Apr 2008 06:08:58 -0500 (CDT)

Subject: CDRH New Update

FDA Home Page | CDRH Home Page | Search | A-Z Index Date: April 18, 2008 The following new items were added to the CDRH web pages on April 17, 2008. Previous CDRH New Items can be found on the CDRHNew Page. Consumer Information on: Talent™ Abdominal Stent Graft System - P070027

Message: 14

From: "U.S. Food & Drug Administration (FDA)" <fda@...>

Date: Fri, 18 Apr 2008 12:50:49 -0500 (CDT)

Subject: CDER New 4/16 - 17/2008

April 17, 2008

Postmarketing Study Commitments: Introduction (updated)

April 16, 2008

CDER issues "Review of Therapeutic Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg"

Drugs@FDA Downloadable Data Files (updated)

Inactive Ingredient Search for Approved Drug Products

New and Generic Drug Approvals

Advicor (niacin lovastatin) Extended Release Tablets, Abbott Labs, Labeling Revision

Diprivan (propofol) Injection, APP Pharma, Labeling Revision

Nallpen in Plastic Container (nafcillin sodium) Injection, Baxter Healthcare, Labeling Revision

Ofloxacin Ophthalmic Solution, Akorn Inc., Approval

TriCor (fenofibrate) Tablets, Abbott Labs, Labeling Revision

Message: 15

From: "U.S. Food & Drug Administration (FDA)" <fda@...>

Date: Fri, 18 Apr 2008 15:06:00 -0500 (CDT)

Subject: California Department of Public Health Warns Consumers Not to Eat Chaca Chaca Chacatrozo Candy Imported from Mexico (April 17)

California Department of Public Health Warns Consumers Not to Eat Chaca Chaca Chacatrozo Candy Imported from Mexico (April 17)Fri, 18 Apr 2008 14:51:00 -0500Dr. Mark Horton, director of the California Department of Public Health (CDPH), today warned consumers not to eat Chaca Chaca Chacatrozo candy imported from

Mexico after tests by CDPH found levels of lead that could cause health problems.

Message: 16

From: "U.S. Food & Drug Administration (FDA)" <fda@...>

Date: Fri, 18 Apr 2008 23:54:24 -0500 (CDT)

Subject: U.S. Food & Drug Administration (FDA) Genomics at FDA Update

Each year the US Food and Drug Administration expends considerable resources convening over 60 advisory committee meetings. This is part of our commitment to engage a wide range of scientific expertise to inform our regulatory decision making process. This is the right thing to do for we must keep up-to-date with the rapidly-changing world of science related to the products we regulate.

My take on this is that something so important deserves careful scrutiny to assure we are doing it the right way. Our Advisory Committee function is therefore one of my highest priorities in our Agency wide process-improvement effort.

The FDA this Week: http://www.fda.gov/oc/vonEschenbach/andys_take/default.html

Archive: http://www.fda.gov/oc/vonEschenbach/andys_take/archive_andys_take.html

This communications from the Commissioner for Food and Drugs, von Eschenbach, will discuss weekly FDA issues of interest to the American consumer and occasionally preview upcoming FDA issues and events.

Message: 17

From: "U.S. Food & Drug Administration (FDA)" <fda@...>

Date: Mon, 14 Apr 2008 13:03:28 -0500 (CDT)

Subject: FDA MedWatch- Herbal Science International, Inc. Recalls Dietary Herbal Supplements Because They May Present A Serious Health Hazard To Consumers

Herbal Science International, Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers. FDA has long regarded dietary supplements containing ephedra, a botanical that contains ephedrine alkaloids, as a potential health hazards because the alkaloid raises blood pressure and otherwise stress the circulatory system. These effects are linked to adverse health effects like heart attacks and stroke. FDA issued a rule in February 2004 prohibiting the sale of dietary supplements containing ephedrine alkaloids because they present an unreasonable risk of

illness or injury.

Two of the recalled products contain aristolochic acid which is a potent carcinogen and nephrotoxin. This chemical can cause serious kidney damage and has been associated with several occurrences of kidney failure. The twelfth recalled product contains human placenta, an ingredient which may transmit disease. Dietary supplements that contain human placenta may not be lawfully marketed in the United States. No illnesses have been reported in connection with the recalled products and distribution of all of the products has ceased. Consumers should immediately discontinue use of the recalled products and return the product(s) to their place of purchase.

Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue and a list of the recalled products at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Herbal

Message: 18

From: "U.S. Food & Drug Administration (FDA)" <fda@...>

Date: Wed, 16 Apr 2008 12:50:12 -0500 (CDT)

Subject: FDA Update for Health Professionals - April 16, 2008

Dear Colleague,

As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent safety information, announcements, product approvals, and upcoming meetings. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.

PRODUCT SAFETY INFORMATION:

Salmonella Illnesses in Multiple States may be Linked to Recently Recalled Cereal (Apr 12)

FDA announced that at least 21 people in 13 states have been diagnosed with salmonellosis that was caused by the same strain of Salmonella that was found in the recently recalled unsweetened Puffed Rice and unsweetened Puffed Wheat Cereals produced by Malt-O-Meal.

Communication About an Ongoing Safety Review of CellCept and Myfortic (Apr 10)

FDA is investigating a potential association between the use of CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid), medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease.

Schwarz Pharma recalls Neupro (Apr

9)

Schwarz Pharma informed healthcare professionals and patients of the recall of Neupro, a transdermal delivery system worn on the skin and used to treat early stage Parkinson’s disease, because of the formation of rotigotine crystals in the patches.

Pfizer updates prescribing information for Exubera (Apr 9)

Pfizer informed healthcare professionals and patients of updated safety information in the WARNINGS section of prescribing information for Exubera, a short-acting insulin you breathe in through your mouth using the Exubera inhaler that helps to control high blood sugar in adults with diabetes.

FDA Finds Hazardous Levels of Selenium in Samples of "Total Body Formula" and "Total Body Mega Formula" (Apr 9)

FDA announced that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products.

PRODUCT APPROVALS:

FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus (Apr 3)

FDA announced the approval of Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children. Rotarix is a liquid and given in a two-dose series to infants from 6 to 24 weeks of age.

For a complete description of approvals of FDA-regulated products, please visit http://www.fda.gov/opacom/7approvl.html

RECENT ANNOUNCEMENTS:

Federal Authorities Seize More Than $100,000 of Unapproved Drugs Marketed as "Natural Supplements" (Apr 9)

At the request of FDA , U.S. Marshals seized more than 14,000 dosage units of Shangai Regular, Shangai Ultra, Super Shangai, Naturalë Super Plus, and Lady Shangai. Although labeled as natural supplements, the seized products were all marketed to treat erectile dysfunction (ED), impotency, and/or to provide sexual enhancement, which caused them to be drugs under the Federal Food, Drug, and Cosmetic Act.

FDA Appoints Dr. M. Torti to Senior Leadership Position (Apr 9)

FDA

announced the appointment of M. Torti, M.D., M.P.H. as Principal Deputy Commissioner and first Chief Scientist. As Chief Scientist and a member of the agency's senior leadership team, Dr. Torti will support the launch of the FDA Fellowship Program, which has the potential to attract up to 2,000 professionals of varying disciplines for a two year training program.

UPCOMING MEETINGS:

Ophthalmic Devices Panel of the Medical Devices Advisory Committee

DATE AND TIME: April 24-25, 8:30 a.m.

LOCATION: Gaithersburg Holiday Inn, Ballroom, 2 Montgomery Village Ave., Gaithersburg , MD

CONTACT: F. Warburton, Center for Devices and Radiological Health, 240-276-4238. More Information

Public Hearing on Antimicrobial Resistance

DATE AND TIME: April 28, 8:00 a.m.

LOCATION: University System of land Shady Grove Center , 9630 Gudelsky Drive , Rockville , MD 20850 .

Written or electronic notices of participation should be submitted by the close of business on Monday, April 21, 2008. Written or electronic comments will be accepted until Monday, May 26, 2008.

Blood Products Advisory Committee

DATE AND TIME: May 1-2, 8:30 a.m.

LOCATION: Hilton Hotel, Washington DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852

CONTACT: W. Jehn or Pearline K. Muckelvene, Center for Biologics Evaluation and Research, 301- 827-0314. More Information

Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

DATE AND TIME: May 5-6, 8:00 a.m.

LOCATION: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., Gaithersburg, MD

CONTACT: Watkins, Center for Drug Evaluation and Research, 301-827-7001. More Information

Anesthetic and Life Support Drugs Advisory Committee

DATE AND TIME: May 7, 8:00 a.m.

LOCATION: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., Gaithersburg, MD

CONTACT: Watkins, Center for Drug Evaluation and Research, 301-827-7001. More Information

Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee

DATE AND TIME: May 16, 8:00 a.m.

LOCATION: Holiday Inn, Grand Ballroom, Two Montgomery Village Ave., Gaithersburg , MD

CONTACT: , Center for Devices and Radiological Health, 240-276-4100. More Information

RESOURCES:

A Guide to Drug Safety Terms at FDA

FDA approves a drug for marketing after determining that the drug's benefits of use outweigh the risks for the condition that the drug will treat. But even with a rigorous evaluation process, some safety problems surface only after a drug has been on the market and has been used in a broader population. This guide offers descriptions of some of the drug safety terms commonly used by FDA throughout the life cycle of a

drug.

If you have any questions, you may send an email to webmail@... or contact us at the numbers listed below. If you do not wish to receive this information updates, you may unsubscribe at this link: FDA Consumer Health Information .

Sincerely,

L. , SBB(ASCP) Janelle Derbis, PharmD

Office of Special Health Issues Office of Special Health Issues

U.S. Food and Drug Administration U.S. Food and Drug Administration

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