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Hello,

It's me again. As soon as I replied to one article by a smart reader, another one comes to me. The

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

multiple question is 'Can you defend yourself in court against a radar device better than a cops' simple o

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

Examples of combination products may in

bservation of your speed'?

The answer is yes to both. In other words, the radar device has been proven to

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

sometimes be 'out of calibration'. Also, you could make a case that the police unit speedometer following

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

you is ' out of calibration'. By the way, you better used exactly what I said, 'out of calibration'. Rada

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

Combination pro

r devices have been known to be 'out of calibration' by as much as 20 miles per hour. WOW!

Now here's the

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

dilemma, a typical traffic citation cost about $100.00. If you fight the ticket yourself and win, good. B

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

t take in to consideration the time you will have spent coming back to court again. Will you have lost mon

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

ey from your job in excess of the citation? Also, if you lose, you will pay the citation plus court cost.

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

Now, I'm not saying pay an illegally issue citation, I'm just saying consider the cost. I have noticed th

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

t most people will pay the ticket with no defense. But there are some people like me, who will fight a $100

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

Following aspects would a

.00 ticket harder than a chicken attempting to escape a fox.

We fight on principle, not cost. We get a joy

dd to the challenges in developing combination products:

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

out of winning.

There is another reason besides increase insurance cost to fight a ticket. If your occup

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

ation is that of a driver. This could cost you your job. Then by all means fight it. And I hope you're

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

ot a principled person that happens to be a driver! All hell will break loose. You will tie the courts' lo

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

gs for years (ha-ha ).

But seriously, consider the cost. If you were speeding pay the ticket. If you wer

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

Professional from academic institutions, pharmaceutical industries, health care indust

e not speeding you might still pay the ticket. But this one thing I must say, if the cop was a rogue cop

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

ho gave you a citation for doing 55 miles per hour in a 20, fight it. And when you win, go to the internal

.

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

affairs department and report him. They will start checking up on his citation log. If you lose your cas

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

Companies that provide selfless information through particip

e, still report him. You must get this cop off the street. Drive safe, obey the laws, and arrive home safe

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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