E-Articles - Health and Fitness

The American Diabetes Association has been pushing efforts to combat diabetes through their comprehensive Diabetes Prevention Program. The DPP was c

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

onducted over several medical centers, involving participants who volunteered to have their eating and activity habits monitored and to follow dieta

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

Examples of combination products may in

ry and exercise recommendations. Among the astounding findings of the said program is the correlation between the causes and prevention of diabetes

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

with that of obesity. Even so, health programs such as the DPP could not account and counter the entire problem with weight-gain alone. People of po

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

wer have to do something because they can.

Regrettably, public policy and bills on obesity have not been eagerly pushed through enough against one

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

Combination pro

f the gravest threats to long-term health. Legislators are only as eager to listen on the chitchat-debates rather than to act (immediately) on the r

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

equired public policy and bills on obesity. Particular groups and districts though are positively assertive. Some state-lawmakers are forwarding bi

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

lls requiring fast food and chain restaurants to post nutrition information such as caloric, fat and sugar content on menus to standardize public aw

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

areness on obesity. Other states are considering public policies restricting the sale of soda, candy, and other junk-foods in schools under jurisdic

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

tion, while others are appointing commissions for research or imposing physical education standards in schools. Others still propose public policy a

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

d bills on obesity imposing tax not only on fatty-foods, but also on sedentary models like movie-tickets, video-games and DVD-rentals, to be used as

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

Following aspects would a

fund for nutrition and exercise programs.

Physicians, diet gurus, women’s magazines and concerned units have long been devoting to the problem of

dd to the challenges in developing combination products:

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

obesity. It may be time though for the government to muster extra interest on the issue. Obesity could be looked at as a matter of personal choice y

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

et it is also a serious societal toll worthy to be considered as government problem. Policy-makers may be torn between the pro and anti obesity bill

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

s, yet they could not neglect the matter altogether.

The need for adequate public policy and bills on obesity is just as crucial and potential as t

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

e fight of the anti-smoking campaigns of the 90’s. It could not be denied that obesity has become an epidemic affecting over 60M of the population,

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

Professional from academic institutions, pharmaceutical industries, health care indust

and a most notable cause of preventable deaths.

And not only does obesity pose serious health-risks to the majority of the population, but it also

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

escalates the government’s total spending on the disease. Hundred billions are spent annually on obesity, directly and indirectly, making it a major

.

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

cause of concern for families, insurance corporations, and the government. If these two reasons are not enough to call for more public policy and b

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

Companies that provide selfless information through particip

ills on obesity, then the government itself is in grave threat. It turns out that obesity is not just a health concern but a political issue as well

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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