Actual - Legal

Hiring a lawyer can be equal to finding an alternate soul or conscience. The lawyer must not just be qualified or competent but care about wh

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

at happens to you. Just because x,y, or z was the greatest lawyer for family or friends does not mean that they will be suitable for you.

T

; 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 important thing is to do your homework and find out which lawyers in your area handle cases or legal work like yours and what their success

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

rate is. The next step in to set up appointments with at least 3-4 lawyers from your list.

When you meet with the lawyer keep a file ready

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

ith a precise note on your problem that needs legal help. Ask the lawyers office whether they would like you to send the file a day or two ah

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

Combination pro

ad so that the lawyer will go through the file before the meeting.

According to experts you must go armed with a list of questions to ask th

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 lawyer. Based on the answers you get you will be able to judge whether or not the lawyer is the “perfect one.”

Ideally you must sit down a

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

d coin questions that pertain to the legal work you need done, among the questions are the following 10 important ones:

1. How many cases or

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

files have you handled similar to mine?

2. How long have you been practicing law and where did you qualify from?

3. What is your frank opin

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

ion on my file? Any lawyer who gives extremely positive outcome promises is to be avoided. A sensible lawyer will explain the pros and cons o

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

your file and indicate what he thinks will happen.

4. Do you think we should file a case? Or are there other options? Any professional lawy

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

Following aspects would a

r will be more than willing to suggest alternative ways to solve problems.

5. Ask about costs of legal work along with break up. Most profes

dd to the challenges in developing combination products:

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

sional lawyers will give you an approximate estimate and explain that costs may escalate depending on how the case progresses.

6. Ask about

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

ow similar cases progressed and weigh how honest the answer is. Any lawyer worth his salt will not paint just a rosy picture. 7. Enquire how

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

work is carried out and what the client-lawyer equation will be. You must understand how the lawyer will keep you in the loop and how long th

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

e legal process is likely to take.

8. Ask whether the legal work will be handled by the lawyer personally of by assistants.

9. How do you n

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

Professional from academic institutions, pharmaceutical industries, health care indust

rmally proceed, aggressively, unyieldingly, or passively? And do you always put the client’s interest ahead of yours?

10. If the case requ

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

res out of town visits will you go yourself or hire local lawyers? This is important as only the lawyer will know the intricacies of the case

.

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

and not any new person just appointed for the day or appearance. Remember a stand in will not take deep abiding interest, he or she will jus

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

Companies that provide selfless information through particip

do what is asked of them.

Before hiring a lawyer you need to be sure he or she is the right one and will see the case or work to completion

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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