FDA Issues Draft Guidelines To Eliminate Microbial Contamination In Tomatoes, Leafy Greens, And Melons.

The U.S. Food and Drug Administration has published three draft guidances designed to help growers and others across the entire supply chain minimize or eliminate microbial contamination in tomatoes, leafy greens, and melons.

The guidances are, in part, based on those originally developed by the produce industry with assistance from FDA. They represent the first step in a fundamental shift in strategy for the agency in the prevention of foodborne hazards associated with fresh fruits and vegetables.

“These guidances embody the Obama Administration’s and FDA’s prevention-oriented food safety strategy,” said FDA Commissioner Margaret A. Hamburg, M.D. “They will be made final as soon as possible after public comment, and will be followed within two years by enforceable standards for fresh produce.”

These commodity-specific guidances were called for by the President’s Food Safety Working Group, which recommends a new, public-health focused approach to food safety. In a report issued earlier this month, the working group made recommendations aimed at creating a stronger food safety system. The recommendations stem from three core food safety principles:

• Prevent harm to consumers
• Use good data and analysis to ensure effective food safety inspections and enforcement of the law
• Identify outbreaks of foodborne illness quickly and stop them

Key elements of the draft guidances related to the working group’s strategies include:

• An acceptable baseline standard of industry practices that help both domestic and foreign firms minimize the risk for microbial contamination of their products throughout the entire supply chain
• Recommendations regarding growing, harvesting, packing, processing, transportation, and distribution of the product
• Recommendations for recordkeeping, including some that will help the FDA determine more quickly the source of outbreaks that do occur.

Comments on FDA’s guidance documents may be submitted at any time. However, to ensure that comments are received in time for consideration in drafting final versions of these guidance documents, written or electronic comments should be submitted within 90 days of publication in the Federal Register. See http://www.regulations.gov for information.

• News Release: HHS Secretary Sebelius, Agriculture Secretary Vilsack Announce New Strategies to Keep America's Food Supply Safe
• Questions and Answers on FDA’s Proposed Commodity-Specific Guidances (CSGs)
• The Draft Guidances
  • Guide to Minimize Microbial Food Safety Hazards of Tomatoes
  • Guide to Minimize Microbial Food Safety Hazards of Melons
  • Guide to Minimize Microbial Food Safety Hazards of Leafy Greens

Tags: Microbial Contamination, FDA Guidance, foodborne hazards

Onglyza (saxagliptin), New Drug To Treat Type 2 Diabetes, Approved By FDA

For Immediate Release: July 31, 2009

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves New Drug Treatment for Type 2 Diabetes

The U.S. Food and Drug Administration today approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels.

The hormone insulin keeps blood sugar (glucose) levels within a narrow range in people who don’t have diabetes. People with Type 2 diabetes are either resistant to insulin or do not produce enough insulin to maintain normal blood sugar levels.

Onglyza is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which stimulate the pancreas to make more insulin after eating a meal.

“Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes,” said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.”

The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.

Approval of Onglyza was primarily based on the results of eight clinical trials. The application seeking FDA approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. Although Onglyza was not associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events, the FDA is requiring a postmarket study that will specifically evaluate cardiovascular safety in a higher risk population.

Onglyza is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., and marketed by Bristol-Myers and AstraZeneca Pharmaceuticals LP, of Wilmington, Del.

Tags: Onglyza, saxagliptin, Type 2 Diabetes, FDA Approval, dipeptidyl peptidase-4, Bristol-Myers Squibb

Abbott Vascular Recalls POWERSAIL® Coronary Dilatation Catheters.

Abbott Vascular has recalled three lots of POWERSAIL® Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints (one from each lot) that the distal shaft of the catheter exhibited damage.
Recallr: Abbott Recalls POWERSAIL® Coronary Dilatation Catheters
Tags: POWERSAIL® Coronary Dilatation Catheters recall, Abbott Vascular recall, FDA Recall, powersail recall, Coronary Dilatation Catheter recall

Guidance for Industry, Drug-Induced Liver Injury

FDA has released a guidance to assist the pharmaceutical industry and other investigators who are conducting new drug development in assessing the potential for a drug or a product to cause severe liver injury (i.e., irreversible liver failure that is fatal or requires liver transplantation).

In particular, the guidance addresses how laboratory measurements that signal the potential for such drug-induced liver injury (DILI) can be obtained and evaluated during drug development.

This evaluation is important because most drugs that cause severe DILI do so infrequently; typical drug development databases with up to a few thousand subjects exposed to a new drug will not show any cases. Databases may, however, show evidence or signals of a drug’s potential for severe DILI if the clinical and laboratory data are properly evaluated for evidence of lesser injury that may not be severe, but may predict the ability to cause more severe injuries. This guidance describes an approach that can be used to distinguish signals of DILI that identify drugs likely to cause severe liver injury from signals that do not suggest such a potential. This guidance does not address issues of preclinical evaluation for signals of DILI, nor the detection and assessment of DILI after drug approval and marketing.
The guidance is available from FDA.
Follow the link below for a PDF file;
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174090.pdf

Tags: drug-induced liver injury, DILI, drug development databases, FDA Guidance, pharmaceutical industry

New Abd Genetic Drug Approvals By FDA (July 28th 2009)

After being absent for a while, new and generic drug approvals by FDA will be listed again.

Following Drugs were Approved by FDA on July 28, 2009

• • Actonel (risedronate sodium) Tablets, P & G Pharmaceuticals, Inc., Efficacy Supp. w/Clinical Data
  • Amlodipine Besylate and Benazepril Hydrochloride Capsules, Mylan Pharmaceuticals Inc., Tentative Approval
  • Cellcept (mycophenolate mofetil) Tablets, Roche Palo Alto, LLC, Manufacturing Change or Addition
  • Lamivudine and Zidovudine Tablets, Aurobindo Pharma Limited, Tentative Approval
  • Penicillin G Potassium Injection, G.C. Hanford Manufacturing Company, Approval
  • Solodyn (minocycline HCl) Extended Release Tablets, Medicis Pharmaceutical Corporation, Control Supplement
  • Zidovudine Tablets, Aurobindo Pharma Limited, Approval
    

Tags: Actonel, Zidovudine, Solodyn, Penicillin G Potassium, Lamivudine, ZidovudineCellcept, Amlodipine Besylate, Benazepril Hydrochloride

Electronic Cigarettes (e-Cigarettes) Could Increase Nicotine Addiction, FDA Warns

Image From Wikipedia

If you are a smoker, please just stop! You can get help at Smokefree.Gov

FDA and Public Health Experts Warn About Electronic Cigarettes

The U.S. Food and Drug Administration today announced that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.

Electronic cigarettes, also called “e-cigarettes,” are battery-operated devices that generally contain cartridges filled with nicotine, flavor and other chemicals. The electronic cigarette turns nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user.

These products are marketed and sold to young people and are readily available online and in shopping malls. In addition, these products do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. They are also available in different flavors, such as chocolate and mint, which may appeal to young people.

Public health experts expressed concern that electronic cigarettes could increase nicotine addiction and tobacco use in young people. Jonathan Winickoff, M.D., chair of the American Academy of Pediatrics Tobacco Consortium and Jonathan Samet, M.D., director of the Institute for Global Health at the University of Southern California, joined Joshua Sharfstein, M.D., principal deputy commissioner of the FDA, and Matthew McKenna, M.D., director of the Office of Smoking and Health for the Centers for Disease Control and Prevention, to discuss the potential risks associated with the use of electronic cigarettes.

“The FDA is concerned about the safety of these products and how they are marketed to the public,” said Margaret A. Hamburg, M.D., commissioner of food and drugs.

Because these products have not been submitted to the FDA for evaluation or approval, at this time the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user.

The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. These tests indicate that these products contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.

The FDA has been examining and detaining shipments of e-cigarettes at the border and the products it has examined thus far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act. The FDA has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. The agency is also planning additional activities to address its concerns about these products.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of e-cigarettes to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

• Online: http://www.fda.gov/Safety/MedWatch/default.htm
• Regular Mail: use postage-paid FDA form 3500 available at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: (800) FDA-0178
• Phone: (800) FDA-1088

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For More Information
Electronic Cigarettes

Tags: carcinogenic to humans, Electronic Cigarettes, e-Cigarettes, Smokefree.Gov, FDA Advisory

National Institutes of Health Stops Viagra Trial

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped a clinical trial testing a drug treatment for pulmonary hypertension in adults with sickle cell disease nearly one year early due to safety concerns. In an interim review of safety data from 33 participants who completed 16 weeks of treatment, researchers found that, compared to participants on placebo (dummy pill), participants taking sildenafil (Revatio) were significantly more likely to have serious medical problems. The most common problem was episodes of severe pain called sickle cell crises, which resulted in hospitalization. No deaths have been associated with the drug in the clinical trial.

Known as walk-PHaSST, the study was the first multicenter, randomized clinical trial to test the safety and effectiveness of sildenafil for pulmonary hypertension in patients with sickle cell disease, one of the most common genetic blood disorders in the United States. Pulmonary hypertension is a debilitating condition of high blood pressure in the arteries that carry blood to the lungs, which can lead to heart failure and death. Approximately 30 percent of sickle cell disease patients develop pulmonary hypertension, and even mild levels of pulmonary hypertension have been associated with sudden death in people with sickle cell disease.

"The increase in sickle cell medical problems is concern enough for us to stop this clinical trial to protect the safety of our participants," said NHLBI Director Elizabeth G. Nabel, M.D. "We will continue to look into the possible causes of these preliminary results. In the meantime, we encourage patients with sickle cell disease who are taking sildenafil for pulmonary hypertension to talk with their physicians about the potential risks and benefits of the medication and what actions they should consider, including whether to taper off this medication and how to best manage both sickle cell disease and pulmonary hypertension."

Because the medical problems experienced in walk-PHaSST were complications specific to sickle cell disease, "The findings of the walk-PHaSST study should not be applied to other groups of patients with pulmonary hypertension where the drug has been found to be safe and effective," Nabel added.

Researchers are conducting extensive analyses of the study results, which could contribute to recommendations for treating pulmonary hypertension in patients with sickle cell disease. They will prepare reports of their research for publication in peer-reviewed journals.

Walk PHaSST was conducted at the following locations:

• Children's Hospital, Oakland, Calif.
• University of Colorado, Denver
• Howard University Hospital, Washington, D.C.
• University of Illinois at Chicago
• Johns Hopkins Medical Institutions, Baltimore
• NIH Clinical Center, Bethesda, Md.
• Albert Einstein College of Medicine, New York City
• Columbia University, New York City
• Children's Hospital, Pittsburgh
• Imperial College London and Hammersmith Hospital, London, England

Rho Inc. of Chapel Hill, N.C., serves as the data coordinating center. Pfizer provided the treatment drug and placebo for the study.

NHI

Tags: NHLBI, NIH, walk-PHaSST, sildenafil, pulmonary hypertension