Advice Pool - Health and Fitness

Who would believe that fresh spinach could make you sick? But that’s just what happened last winter, when a rash of illnesses broke out tha

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

t were linked to consuming E. coli–contaminated fresh spinach. Since then, you’ve probably wondered what’s safe to eat and what’s not, and

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

what you can do to protect yourself and your family from food borne illnesses. Plenty, it turns out.

Food borne-diseases cause roughly 76

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

million illnesses, 325,000 hospitalizations and about 5,000 deaths in the U.S. each year, according to the Centers for Disease Control and

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

Prevention. To avoid getting sick from contaminated foods, “you don’t need to get paranoid; you just need to be careful,” says Cynthia M. Y

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

oshida, M.D., a gastroenterologist in Charlottesville, VA, and author of No More Digestive Problems (Bantam). Thorough cooking usually kill

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

s most harmful bacteria, so the greatest food safety risks are with raw or undercooked foods. (If you are immunocompromised or have liver d

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

sease, avoid risky foods such as raw shellfish and soft cheeses altogether, Dr. Yoshida advises.) To protect your family from food borne

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

illnesses, you’ll want to follow these five food-safety tips in your kitchen:

Scrub like a surgeon. Lather up with warm

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

water and soap from your fingernails to your wrists for 20 seconds, then dry your hands with paper towels. Wash your hands again whenever y

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ou change tasks—for example, when you switch from cutting meat to making a salad.

Store raw meats safely. Place red meats

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

, poultry and seafood on the bottom shelf of the refrigerator. That way, their juices won’t drip onto other foods and contaminate them.

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

trong>Dedicate cutting boards. Use one board for meats and another for ready-to-eat foods like produce and breads—and keep them se

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

parate. Wash them well with soap and hot water after each use.

Wash produce thoroughly. Even if the label on a bag of let

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

uce says it’s triple-washed, rinse it in a colander for a few minutes. Do the same for all fruits and veggies.

Cook meats properly

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

. The best way to tell if meat or poultry is cooked thoroughly is to insert a meat thermometer into the thickest part. According t

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

o the American Dietetic Association, ground meats, roasts and steaks should be cooked to 160°F, while chicken and turkey should be cooked t

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

o 180°F. After each use, wash the thermometer thoroughly with hot, soapy water. Don’t have a meat thermometer handy? “At least cut into the

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

meat to make sure it’s cooked through,” Dr. Yoshida says. “And there should be no trace of pink in chicken or turkey.” Practicing food sa

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

fety will keep your kitchen germ-free and protect the health of your loved ones--and is there anything more important?

©REMEDY, Spring 200

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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We've all been on the road before and saw someone speeding past at high speeds. Probably, we've wondered why someone like that is allowed to drive. It's true that the streets are a dangerous place, with not speedsters on the road, but also a number of other obstacles that get in the way of a safe and leisurely drive. However, there are plenty of safety precautions put into place to help make that a reality. One of the more common and usually underappreciated examples of this would be speed humps, which are put into place to regulate the speeds of vehicles traveling down the road and to make those roads a safer place for everyone.

The offshore financial centres have been forced in recent years to review almost every aspect of the ways in which they operate in response to the international anti- money laundering laws and initiatives by major economies such as the E.U. and the U.S.A. to increase co-operation in the areas of preventing tax avoidance and tax evasion. These pressures continue and it is clear that the only way forward is for these centres to eliminate, as a priority, all forms of discrimination between different classes of taxpayer.

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