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Having an accident on a motorbike is a lot more traumatic than having on in your car. The injuries can also be a lot more severe. With a car you have the obvious prote

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

ction of your seat belt, air bag and the frame of the car.

I had a motor cycle accident in my early twenties when I was travelling on the back of my boyfriend’s bike.

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

Examples of combination products may in

car pulled out and didn’t see us at all. We were both thrown from the motorbike about fifteen metres. Stupidly that day I had chosen to ware a short skirt. I immedia

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

tely regretted that as I had severe tarmac abrasions all up my legs. My boyfriend was in full leather which saved his skin so his injuries were minimum. My boyfriend h

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

d reservations about me travelling on the back with my skirt and tights on. But every week he would give me a lift when I was wearing leather or jeans and nothing happe

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

Combination pro

ned. So the one summer evening I took a chance and wore a skirt the worst happened.

The women who caused the accident admitted she did not see us and told the police t

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

e same. This was vital evidence for our compensation claim and made the case run quickly and smoothly. I had never heard of compensation claims at the time and it 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

only my boyfriend at the time who was an American that told me we could claim back for the injuries and the cost of new leathers and crash helmets. Once a crash helmet

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

as been in a crash it must be renewed.

Within a week of the accident we went and saw a solicitor with all the details of the accident including the police report refere

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

nce number and the details of the women who caused the accident. We used legal aid to fund the personal injury claim and within 4 months we received money for all of ou

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

expenses. These expenses included our money to replace our damaged leathers and clothes, money to replace our crash helmets, money to touch up the scratches and damage

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

Following aspects would a

to the motorbike. We were also compensated for the pain and suffering we went through. All in all we were repaid for everything and more so it was well worth going th

dd to the challenges in developing combination products:

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

rough the legal system to claim for compensation.

Nowadays there is no legal aid available for personal injury cased. This has been replaced a Conditional Fee Agreemen

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

which is better known as ‘No Win No Fee’. With the ‘No Win No Fee’ agreement you can make a claim without having to make an upfront payment for the services of the law

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

yer. The legal costs are paid by the party responsible for the negligence or their insurance company. If in the event of the case being lost then there are some option

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

available. Some lawyers have relationships with after the event insurers, which means that the legal company with provide an insurance policy. Most companies won’t ch

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

Professional from academic institutions, pharmaceutical industries, health care indust

arge a premium for this although it worth checking as some companies might expect you to pay the premium.

It is important to remember that with the ‘no win no fee’ agre

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

ments the lawyers are effectively working for nothing and just relying on their judgment that they will win the case, so in other words get paid for their work. They ar

.

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

e not likely to take on a case they think they won’t win. If you are wondering if you might be entitled to compensation ask yourself the following question. Have you h

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

Companies that provide selfless information through particip

ve suffered an injury which wasn’t your fault in the last three years? If you answered yes then you will be entitled to compensation and it is your civil right to do so

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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