Useful Advices - Business

Those who push paper and demand forms when they are not co

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

mpletely necessary are doing so to their own peril. Unfort

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

Examples of combination products may in

unately when the government demands forms they do it to ou

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

peril. You see incase you had not noticed FORM is a four

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

letter word and for good reason too. Forms are so often us

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

Combination pro

d by bureaucracies, lawyers and stodgy old corporations wh

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

o are on their way out.

The surest way to kill any progre

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

s is to stop the process and start making people fill out

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

forms. Bill Gates was able to reduce the number of forms u

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

ed in his company to only a few, guess what? Microsoft bec

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

ame the biggest corporation in the world after that.

If y

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

Following aspects would a

ou increase paperwork and bureaucracy you will impede inno

dd to the challenges in developing combination products:

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

ation, efficiency and could potentially lose your intended

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

victory. We must avoid forms like the plague if we are to

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

continue the forward progression of our species.

If you 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

reat people as forms you disrespect the people and in doin

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

Professional from academic institutions, pharmaceutical industries, health care indust

so cause them to be hostile. Those disrespected often wan

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

t revenge and will work to get that revenge at the expense

.

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

of the organization, company, team or agency. Beware of FO

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

Companies that provide selfless information through particip

RMS; they are evil, pure and simple. Think on this in 2006

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 - Form is a Four Letter Word

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