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I am a non-smoker and a passionate anti-smoker and because of this cannot wait unt

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

il the quality of my life outside my home is greatly improved on the 1st of July t

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

Examples of combination products may in

is year. That is the date that smoking in a public place is banned in England.

I

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

ave had so many social events ruined by the thoughtless acts of smokers. The need

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

o smoke during a meal regardless of the effect on others has always left me bewild

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

Combination pro

red and angry. I am all for the right to chose but I don’t believe that most smo

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

ers make a truly informed decision to smoke and even if they have had all the info

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

rmation and advice they think they need to continue, what right do they have to ma

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

e that decision for me and my children?

Passive smoking kills thousands of innoce

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

t people each year because it affects them the same way it does the smoker, by inc

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

easing their risk of heart disease, cancer and respiratory disease.

When I go out

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

Following aspects would a

for a meal or social event I have no intention of interfering with others or makin

dd to the challenges in developing combination products:

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

them feel uncomfortable so why do smokers feel justified in spoiling my evening?

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

hey have no regard for where the trail of their smoke is going as long as it is no

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

t going into their eyes, they never look round to see who is sitting nearby, never

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

ask "is it ok for me to smoke?" I often wonder if I started to flick drink in a pe

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

Professional from academic institutions, pharmaceutical industries, health care indust

sons face how long they would put up with it before complaining, but because smoki

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

g is "allowed" we say nothing or simply choose not to go to a particular venue or

.

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

vent. So roll on 1st of July so that going out stops being a lottery of where you

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

Companies that provide selfless information through particip

an go, who will sit near you and how you feel (or smell) at the end of the evening

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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One of the common errors poor managers make today is to shoot the messenger who brings them bad news. These managers typically want nothing but good news. They often see the bearer of bad news as negative, not a team player or a troublemaker. Their attitude is often:

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