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You’ve been pulled over on what you feel was a bogus speed trap. You’ve got this hugely expensive speeding ticket for trickling a few miles over the speed limit. You feel

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

the officer used excessive tactics in singling you out of the crowd of speed demons out on the Interstate. You feel maybe even it was your own good driving that got you pul

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

Examples of combination products may in

led over as you were the easiest catch! You’ve pleaded your case to the officer as well as family and friends.

Now what are you going to do about it?

Fighting speedin

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

tickets is a ritual as old as time and can be perhaps even more fun. As we cautiously parry forward into the ere looming technology age that’s already consumed us; an age

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

which threatens to take our traditions and rituals, chew them up, and spit them out, leaving a confused and pensive populous lurching for answers; there are still some thing

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

Combination pro

s that will remain (at least for now). Fighting speeding tickets is one of those things. There are a few ways that are effective and may leave you waving to the retreating

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

officer as they continue on for their next victim.

Speeding tickets are like the judicial system. You are always innocent until proven guilty. Most snared speeders think

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

that just because an officer gave them a ticket, they have no options. That is a misnomer which couldn’t be further from the truth.

You most definitely have a right to fig

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

ht; as well you should, if you feel you were wronged. The examples I used above are all very valid reasoning’s for being wrongly accused; unfortunately for you, the wheels

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

f justice grind slowly and often what people opt for; rather than going off and fighting this wrongness; is they just send their check and curse themselves.

This attitude h

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

as far reaching, potentially damning consequences, beginning with increased insurance rates; ending with jail time for unpaid tickets, driving with a suspended license, or a

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

Following aspects would a

ny of the other births from the “just take it” attitude. Rather than letting any of these grievances befall you, you should take positive steps to beat the ticket, beat t

dd to the challenges in developing combination products:

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

e man, beat the system.

As I said, the first line of defense is a good offense. Let’s forget the ticket and go back to the altercation with the officer. A few choice word

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

s for the man in blue can stop you from even getting a ticket in the first place. Were you picked out of a crowd? Did the speed limit just go down? Were you passing anoth

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

er vehicle (in a passing lane)? These are all things in your defense that can stop the whole matter before it starts.

If you’ve missed that opportunity, but remember the e

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

ent vividly, write it out. Include a short, terse, factual letter with your claim of innocence and you may be granted lieneny with only defending your case on the one side.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Just remember, you’re asking for something from them. So be respectful, be gracious, and consider yourself blessed if you’re able to avoid the final step:

Going into cou

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

rt! This is the last option; one people usually balk at for all sorts of reasons: civil court is slow, your case might not be heard, I don’t have all this time off to go an

.

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

fight this stupid ticket. But, if you believe in your case, it’s a step we all should be prepared to take. Fighting speeding tickets is a multi level attack; always remai

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

Companies that provide selfless information through particip

n on guard, look for loopholes, remember you position. But when that letter arrives and you tear it open “Charges DROPPED” there is no other feeling in the world to compare

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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