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Hank called me a while back and asked me to take his brain injury case. Hank wa

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

s new to the Philadelphia area and didn’t know where to find the right lawyer.

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

Examples of combination products may in

e was confused and frightened. He considered ads in the Yellow Pages, but this

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

ust left him more troubled. Finally, he found the Eye and Brain Injury Legal In

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

ormation Center. He e-mailed some questions about his case. He also expressed

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

Combination pro

is concern that he didn’t know any lawyers in Philadelphia and asked who he shou

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

d trust me with his important legal rights.

I told him that when he found a law

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

er, he should be the most important client in that lawyer's office and that he s

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

ould get personalized, prompt attention. I told him that his lawyer to:

• Ans

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

er all of his clients’ calls personally
• Return all missed calls by the ne

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

t day
• Provide honest answers to his clients’ questions
• Work hard t

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

Following aspects would a

o achieve the best possible result for every client
• Provide straight advi

dd to the challenges in developing combination products:

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

e at every stage of the case
• Truly care about all clients and their well

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

eing
• Charge reasonable attorney fees
• Hold down litigation costs to

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

the best of his ability
• Push for large settlements at an early date

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

Work to maximize settlement value
• Keep every case on the “front burner”

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

Professional from academic institutions, pharmaceutical industries, health care indust

Treat your selection of a personal injury lawyer the way you would any matter of

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

importance in your life. Your lawyer’s reputation for ethics, credibility and d

.

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

pendability is crucial to your success. You have the right to competent, reliab

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

Companies that provide selfless information through particip

e representation and courteous treatment by a lawyer in whom you have confidence

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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