Advice You - Business

Some would say about certain issues that the means do not justify the ends. Well m

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

ore often the ends do not justify the means. For instance if you are trying to acc

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

Examples of combination products may in

omplish something and know that if you do use the most approved PC methods then yo

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

u cannot get to the desired results, but use those methods anyway as to not appear

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

to offend anyone, then in the end you offend everyone by wasting their time and b

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

Combination pro

y failure of the project.

What we must do is to protect original thoughts and not

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

suppress them and allow them to enter the public domain for the common good witho

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

ut denying the producer of the thought their benefits. The first problem we encoun

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

ter in this regard is the PTO Patent and Trademark office; a giant monstrosity of

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

biblical bureaucratic proportions.

If someone has an idea or many ideas and canno

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

t easily register them without undue hardship and cost, then that individual is li

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

Following aspects would a

kely to never bother to continue to have original thoughts and we all lose as a co

dd to the challenges in developing combination products:

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

untry because of it. Concept patents are outrageously expensive, take years to get

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

approved and you for the most part need to hire an attorney to do them. All this

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

costs money and causes a lessoning of thinking or flow of thought to the common go

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

od of mankind.

One discovery in one industry will surely lead to several more in

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

Professional from academic institutions, pharmaceutical industries, health care indust

others. We need to allow for the flow of thought and not stifle the speed of that

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

flow through a bureaucratic process. The PTO is expanding in Washington and will m

.

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

ove into a new 600 million dollar campus, but really it needs to be a huge compute

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

Companies that provide selfless information through particip

r system. If you create artificial barriers to thought then thought stops flowing.

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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Advice You - PTO; Justification of the Means and the Ends

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