Answers - Legal

A common scenario after filing a claim for compensation in a major personal injury case goes something like this:

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

even before the trauma of the accident tapers off and the wounds start to heal, the victim finds himself under tre

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

Examples of combination products may in

mendous financial stress. The final verdict on the suit takes time. Meanwhile, medical bills and other expenses p

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

ile up. His paychecks may have stopped because he is unable to work. At this juncture, a settlement is offered for

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

a much lower amount than what was claimed. The desperate victim accepts it against his attorney’s advice.

It cou

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

Combination pro

ld be a different story altogether if he had approached the personal injury funding institutions catering to the L

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

os Angeles, CA area. All that he has to do is to contact one of them online or by telephone. If all the necessary

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

papers are submitted without delay and the financier is satisfied, the request could be approved within 48 hours!

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

Even citizens with bad credit can avail themselves of this, provided they are not bankrupt.

The procedure is that

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

the funding institution contacts the victim’s attorney for copies of relevant documents, and details of the case.

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

The primary basis for a decision on the application is how strong the claim is. Once it is approved the applicant

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

Following aspects would a

has to sign an agreement with the funding institution.

If more money is required at a later date, in case the cl

dd to the challenges in developing combination products:

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

aim drags on or goes into appeal, applications for extra funding are entertained. It may also be possible to get a

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

dditional funds from a different agency. Repayment is out of the proceeds received from the claim. There are no mo

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

nthly payments. If the claim is rejected, no repayment is required; the financier absorbs the loss.

All these sou

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

nd fine. Naturally, there is a cost involved. The amount to be repaid is arrived at by multiplying the advanced fu

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd by a ‘factor’ into which the interest is built. Because of the cost and for his or her own reasons, sometimes t

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

he attorney concerned might discourage clients from availing such funding.

But the victim is the best judge of hi

.

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

s needs. If he decides to accept funding, it should be limited to covering the bare essentials only. He should stu

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

Companies that provide selfless information through particip

dy the conditions tagged to the funding, look for hidden costs and be wary of schemes that require upfront payment

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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Answers - Los Angeles Personal Injury Funding

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