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Greetings to all,

This question was asked of me the other day. Both are very

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

good questions. The first, can a citizen be arrested for speeding? The answe

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

Examples of combination products may in

r is yes. If you're speeding on a residential street with a posted speed of l

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

ets say, 40 mph, and you're doing 70 mph, you can be arrested. If traveling d

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

own the interstate where the posted speed limit is 70 mph and you're doing 10

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

Combination pro

0 mph, yes you can be arrested.

In both cases you can be issued a citation,

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

but also arrested for negligent operation of a vehicle or a similar charge (d

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

epending on the state's wording for this charge). The charge relates to the f

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

act that your driving at this speed is endangering the public. You're drivin

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

g so fast that you are likely to lose control and kill a citizen.

I have per

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

sonally as a former police officer arrested a driver for this violation.

The

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

Following aspects would a

second question, can you be arrested for a parking violation? The answer is

dd to the challenges in developing combination products:

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

no. But I've seen a citizen arrested for some other charge that began from a

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

parking violation. If an officer asked you to move an illegally park vehicle

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

and you challenge his authority, he could arrest you for failure to comply or

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

resisting arrest. Some people think that resisting arrest means you must hav

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

Professional from academic institutions, pharmaceutical industries, health care indust

e a physical struggle with the officer. Not so. The mere fact that you resist

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

ed verbally is sufficient for this charge. I personally never arrested a citi

.

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

zen for a parking violation. But there are rogue cops that will cite or arres

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

Companies that provide selfless information through particip

t you for almost anything.

Drive safe, obey all laws, and arrive home safely

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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