Useful Advices - Business

Something about the video guy set off my internal alarm.

I got the feeling he wasn’t quite on the up and u

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

p; you couldn’t count on him to do his job well.

Still, his is one of the few outfits that can transfer vi

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

Examples of combination products may in

eo from a European to an American format, and I wanted this tape I own to work on my playback machines.

He

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

called, said it was ready, and I paid and left with it.

The next day I returned with the DVD he had burned

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

because it didn’t work right in my machines. He blamed them for being too old, and the obvious implication

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

Combination pro

was, tough for you, buddy!

“Buy a new VCR!” he chided.

I said, more or less, if you thought there was any

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

chance what you were going to make wouldn’t work on my machine, you should have warned me in advance. Then,

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

I could have made an informed choice, weighing the risks and rewards. In light of the fact you didn’t, you

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

should either refund my money or take another shot at making a video that will work.

Again, he stonewalled

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

Finally, I’d had enough.

“Look, you’re straining my patience,” and with those words I reached into my wa

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

let and plunked onto the counter a card.”

“I’m a lawyer, and we can do this the easy way or the hard way.

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

Following aspects would a

If you like we can take it to Small Claims Court, and the judge will tell you just what I told you, but you

dd to the challenges in developing combination products:

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

ll miss a half or full day of work.”

Within a minute, we settled the matter, amicably.

There is an implie

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

warranty of fitness and use that comes along with most products. The law provides this; you won’t get it o

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

n a printed document that comes with the product.

Call it a guarantee, provided by law. The video guy, by

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

lacing into commerce the DVD’s he makes is saying, implicitly, they’ll work for their intended purpose, and

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

Professional from academic institutions, pharmaceutical industries, health care indust

they’ll work on your machine.

And they must, or you can rescind your contract; i.e. return an item when yo

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

u first learn about the defect, and demand a refund.

There are some exceptions such as products that are s

.

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

ld on an “as-is” basis, where you are notified, in advance, that the sale is final.

Don't be suckered into

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

Companies that provide selfless information through particip

thinking you’re out of luck just because some blowhard says so.

His intimidation can’t stand up to the law

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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Useful Advices - Customer Satisfaction Attorney Says Consumer Products Come With An Invisible Warranty!

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