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All businesses should volunteer to help out in the community especially to help youth

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

organizations. But what happens when you help a youth organization like the Boy Scouts

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

Examples of combination products may in

and find that it is not politically correct? What happens when the Gay and Lesbian Co

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

mmunity or a fringe within their community threatens to boycott your company?

The epi

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

sode described above happened to my company and it has long past. Believe me I can hol

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

Combination pro

d my own, no worries, really good at what I do and very strategic in marketing, but it

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

is troubling to be put in that situation. I was asked once when I mentioned this was:

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

“What is the Gay Fringe is doing to you!”

Well they made it sound like I am afraid,

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

worried or some such non-sense, no way. A little pissed off indeed back then, but hard

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

ly worried about my company or our Brand Name in the market place, our customers love

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

s, I know it and I am sure those who threatened figured that out quickly enough. They

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

Following aspects would a

probably looked foolish in spreading negative comments. In fact this is the feedback I

dd to the challenges in developing combination products:

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

was getting in the market place it happened.

Well the threat to boycott my company c

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

ame after I refused to stop helping a Boy Scout Group in a community fundraiser. But i

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

t did not stop there the BS [which I should not have to use abbreviations] went on for

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

weeks on end. After explaining this I was then asked; “Are these networks of homosexu

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

Professional from academic institutions, pharmaceutical industries, health care indust

als involved in the boycotts or in harming your business in other ways?” Yes, indeed t

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

hey did or tried and it involved abuse of power, actually caused me to lose complete f

.

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

aith in government at all levels, but it was a good lesson, so actually a blessing. Yo

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

Companies that provide selfless information through particip

u must help the community, but beware, as there are often risks. Consider 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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