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When you are seeking legal advice it is very important to find the right lawyer. There are good and bad ones out

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

there and you need to choose one that will fight for you and try to get results that are acceptable. Price is 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

ten a problem as there are a lot of attorneys who will over charge you.

One of the best ways to find an attorne

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

is to look in your yellow pages. Here you will find listings of all your local attorneys. Here are some points

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

to look for:

- Try to find a lawyer who is from the same state and city as you are and is familiar with all the

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

Combination pro

state laws.

- The next step is to find a firm that deals with your particular type of case, as many attorneys w

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

ll specialize in different fields. Because there are so many different rules and regulations for every field it

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

is rare to find an attorney who will deal with more than one field.

- Try to look for an experienced attorney,

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

ho will be familiar with all the courthouse rules, regulations and judges.

- It is important for your legal adv

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

sor to be board certified in the state where they are practicing.

- It is wise to check out their reputation if

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

possible, with general public or peers.

- They should carry malpractice insurance.

- Try to get a free initial

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

Following aspects would a

consultation.

- Be careful when you sign a contract. There should not be any hidden fees and everything should

dd to the challenges in developing combination products:

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

be clear and up front. Make sure fees are discussed and agreed on before signing. Read the contract very careful

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

y.

Make a list of a few lawyers before calling them. Ask pertinent questions and be careful of how they tackle

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

and answer them. Be careful to meet with the same attorney who will be handling your case. Here are some questio

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

s that you might want to ask:

- Try to find out how much experience they have in cases similar to yours.

- Try

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

Professional from academic institutions, pharmaceutical industries, health care indust

to make sure the case can be resolved in your favor and what your options may be.

- How long it will take for s

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

ettlement.

- What your out of pocket expenses might be.

- Their fee and total bill.

- Make sure they will kee

.

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

you informed and how they intend to do this.

When you seek legal advice try to keep these points in mind when

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

Companies that provide selfless information through particip

hoosing your lawyer. When you take care to choose wisely you will be able to get the best service for your money

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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