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First let’s make a distinction between:

· Talking to a lawyer, and

· Hiring a lawyer

People consult lawyers all the time for a host of reasons. If you’re thinking you might need to hire one, the first thing to do

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

is talk to some. Set up some initial consultations, which are often free of charge, to see if that lawyer is the right one for you.

If the consultation is not free of charge, consider whether it might be money wel

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

Examples of combination products may in

spent for the information you could learn. Law is a complex thing with many exceptions, obscurities, unique details etc. Only a lawyer with experience in the field that concerns you can give you the facts and guida

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

ce you may need.

Interview some lawyers

If you make 3 or 4 appointments with possible lawyers, present your situation to them, and listen to their responses, you will probably know by the end of that whether you n

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

ed to hire one. And you’ll know whether one of those 3 or 4 will be the right one.

In getting ready for those initial consultations, you’ll need to think about your situation. One of the first things to ask yoursel

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

Combination pro

is: What’s at stake here?

Pros and Cons

Try making two columns on a piece of paper.

· Why I need a lawyer

· Why maybe I don’t need one

Write down all the ideas that occur to you as to what you might gain by hi

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

ring an attorney, and what you might lose by it. Don’t censor yourself, just write down all the thoughts that come to you, both pro and con. It’s a good way to clear the mind and get a better focus on what’s really

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

mportant and what’s perhaps just some temporary bee in your bonnet.

Beware the statute of limitations

If you’ve been harmed in some way and feel you should be paid compensation, be aware that there’s almost certai

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

ly a time limit for you to file a claim. From the date of your injury (whether physical, financial, or whatever kind of injury), there’s a clock ticking off the days and weeks during which you may file for redress.

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

It may be several years, or in some instances may be only several weeks. At any rate, this is a good first question to ask a lawyer when you have an initial consultation. The answer will give you an idea of how quic

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

ly you must proceed in filing any claim.

Remember too that if you do hire a lawyer, time will be required for him or her to gather information and prepare a lawsuit for you. This preparation must all be done within

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

Following aspects would a

the statute of limitations.

Financial considerations

Like all professional services, those of a lawyer cost money. If that gives you pause, follow your thoughts on the subject.

· How much money is at stake in yo

dd to the challenges in developing combination products:

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

r situation?

· What exactly would a given lawyer charge you?

· Would you be paying fees as things progress?

· Would it be a percentage of any compensation you might be awarded?

· What’s the comparison between wh

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

t the lawyer might cost and what you might receive?

While these are all questions to ask yourself, you won’t necessarily be able to answer them, and they’re all questions you can ask each lawyer you interview.

Alt

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

rnatives to hiring an attorney

· Many community groups (e.g., civil rights groups, elder groups) offer free legal advice

· Many businesses use mediation or arbitration to resolve disputes

· Many industries are re

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

ulated, so you could talk to someone at the state regulatory agency

Depending on what your situation is, these resources may fill your need, or may give you missing pieces of information that help you make a decisi

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

Professional from academic institutions, pharmaceutical industries, health care indust

on on hiring a lawyer.

Do you want legal defense or compensation for an injury?

Most lawyers specialize in certain fields. By asking around among your friends, neighbors, co-workers etc., you could learn the names

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

of law firms who specialize in the type of law relevant to your situation.

If you do hire a lawyer, you’ll want one who has extensive experience in the type of legal work you need. For example, if you’ve been hurt

.

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

n a car accident, you won’t want to hire a lawyer who specializes in insurance defense, because that mindset is diametrically opposed to the mindset you’ll want in your personal injury lawyer.

Whatever you situatio

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

Companies that provide selfless information through particip

is, take some time to think things through, but not too much time before having some initial consultations, because of that statute of limitations. Once that time limit is up, there’ll be no recourse at all for you

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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