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If you're a pet owner, you probably heard about it. In February and March of this year, news organizations reported a sudden and alarming epidemic of kidney failure a

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

mong cats and dogs. Though the numbers weren't and aren't officially known, some sources reported thousands of cat deaths across the country, plus many thousands of p

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

Examples of combination products may in

ts becoming seriously ill.

Soon after the outbreak began, the culprit was identified. A single manufacturer, whose wet pet foods are sold under dozens of familiar br

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

and names, had allowed a lethal substance known as melamine to enter their products. This error wasn't discovered until over 60 million potentially contaminated units

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

had already hit store shelves.

The ensuing pet food recall caught the attention of pet owners nationwide. Media-provided lists of affected products seemed to grow by

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

Combination pro

the hour. Soon, huge voids appeared on the shelves of supermarket pet food aisles.

The symptoms of melamine poisoning provide little comfort. Even for animals who s

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

urvive, symptoms include vomiting, diarrhea, lethargy, depression, kidney stones, loss of appetite, and permanent kidney damage. To those of us who think of our pets a

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

children, the thought of our cats or dogs suffering these symptoms is unbearable.

Also of little comfort, and exacerbating many pet owners' unwillingness to re-intro

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

duce wet foods into our pets' diets, is the current lack of official government oversight over pet food products. Of course, this doesn't have to be a terrible thing.

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

After all, most pet food makers understand that not to self-regulate is simply bad business. To allow an outbreak like the one that occurred this year is the quickes

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

way to go out of business.

Even so, as this case has illustrated, lack of government oversight leaves our pets vulnerable to accidents and mistakes. Most pet food m

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

Following aspects would a

akers receive their raw materials from a variety of sources. In fact, it's been suggested that the melamine-contaminated material in these products came from China.

dd to the challenges in developing combination products:

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

o, with materials coming from all over, what can be done to ensure that pet foods will not be contaminated in the future?

Obviously, we can do little to ensure that p

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

roducts made in China are not contaminated, but on our side, there is plenty we can do. The key isn't to prevent contamination where prevention is impossible, but rat

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

er to detect contamination before it reaches our pets' food bowls. Specifically, before a batch of food lands on store shelves, we can perform melamine testing.

Many

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

companies, along all steps of the pet food manufacturing process, already perform melamine testing. Testing can be done not only on the finished food product, but als

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

Professional from academic institutions, pharmaceutical industries, health care indust

o on the product's ingredients, which, again, tend to come from all over. For example, if you're an importer of materials that go into pet food products, to invest in

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

a melamine testing service could potentially save your company from this type of embarrassment and disgrace.

In other words, though there is no official FDA of pet fo

.

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

od, it is in the best interests of pets, pet owners, and pet food makers to make the entire process as safe and carefully-watched as possible. Thus, from a business p

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

Companies that provide selfless information through particip

rspective, melamine testing is both smart and ethical. Not only will it keep pet food manufacturers in business, but it will also keep our beloved pets safe from harm

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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