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1. Get organized. Prepare detailed written notes outlining your legal problem or questions. Provide the lawyer all the details, and let he or she decide what is important to your case.

2. Complete and honest disclosure of all facts. It is very important that you provide a complete and honest description of your problem, including information that may be favorable, unfavorable, or embarrassing. Leaving out a minor fact or detail could have a huge negative impact on your case. Only if

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

you fully disclose the facts about your situation can an attorney properly advise you. Remember that there are strict rules that require an attorney to keep your information confidential.

3. Discuss fees. Your attorney will be ready to discuss fees at the first meeting, and you should be ready to do the same. You can and should negotiate fees and discuss payment plans with your attorney. Get your agreement in writing and keep a copy for your file. Most disputes about fees happen beca

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

Examples of combination products may in

use there is no written record of an agreement.

4. Ask a lawyer questions. In order for your attorney to serve you better, you must understand all aspects of your case and the legal process. Understanding the process will help you understand how the lawyer is working and what type of information is needed on your case. But remember, you are paying for your attorney’s time. It is more cost effective to ask several questions at once instead of calling your attorney every time one quest

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

ion comes to mind. You may be charged for each call depending on your fee agreement.

5. Understand what you sign. Before you sign a document, ask your attorney to fully explain to your satisfaction any document. What can be clear and routine to an attorney can be confusing to people without formal legal training.

6. Keep your own records. Ask for copies of all letters and documents prepared on your case. You should also keep the written fee agreement between you and your attorney 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

he file. You may have to access this information at some point in the future so it is important to maintain records.

7. Legal advice. Give careful and thoughtful consideration to what your attorney advises. The attorney’s judgments are based on legal training and experience. Remember that lawyers cannot work magic. No attorney wins every case, and sometimes the best legal advice may not be what you want to hear. Your attorney will provide advice that has your best legal interests in

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

Combination pro

mind. The central focus of any case is the facts. Each side will have facts that contribute to the outcome of the case. It is the lawyer’s responsibility to make you aware of the potential outcome of your case based on the facts.

HOW DO I PREPARE AND WHAT SHOULD I TAKE TO THE FIRST INTERVIEW?
Plan to go to the first interview with an open mind. You do not have to decide to employ the attorney with whom you are interviewing until you have had time to think about the interview a

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

nd your experience in communicating with the lawyer.

When you go to your initial consultation, it is important to have with you a written summary, or detailed notes outlining your problem. The notes or summary should include:
1. Names, addresses and phone numbers of all persons or companies involved
2. All documents which are part of your case, including
a. Documents you have received from another attorney
b. Documents you have received from a court
c. Jo

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

urnals
d. Written Correspondence (includes emails)
e. Receipts
f. Contracts
g. Medical bills
h. Repair estimates
i. Checks, etc.
j. Pictures
k. Written notes detailing the history of your situation

The attorney may ask you to deliver written materials in advance of your first interview in order to have adequate time to review them. You may prefer to provide copies rather than originals at the initial interview. Remember that all la

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

yers are subject to attorney-client privilege and therefore, must maintain any information in strict confidence.

Next, prepare a list of questions for the attorney, such as:
1. Are you specialized and/or experienced in my type of problem?
2. Will you or one of your associates be handling my case?
3. Will you regularly contact me about the status of my case?
4. Will I be provided with copies of all important documents, and will there be a charge for those doc

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

uments?
5. Will I be able to make the final decision on my case?
6. What is your estimate of time needed to complete my case?
7. What is the hourly billable rate?
8. What amount of retainer is required to request your services?

REMEMBER: When you hire an attorney, the attorney will be working for you. He or she should be genuinely interested in your problem and in giving you the best possible advice. The attorney may not be able to accomplish everything yo

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

u wish because of the facts or the laws that apply in your case. Many times the best advice an attorney can give will be to avoid court action. He or she may suggest other methods to resolve your matter, such as mediation.

WHAT SHOULD I EXPECT OF MY ATTORNEY?

Here are a few tips about what to expect from your attorney. Your attorney should:
1. Give you candid, honest advice;
2. Tell you the strong and weak points of your case; this includes potential outcomes based o

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

Following aspects would a

n facts and your instructions on how to proceed
3. Keep you informed and follow your instructions, within the bounds of the law;
4. Protect and defend you to the best of his or her ability and to the fullest extent of the law;
5. While representing you, not represent any other client whose interests conflict with yours;
6. Provide you, if you ask, with copies of all letters and documents involved in your case;
7. Provide an itemized bill of all work done f

dd to the challenges in developing combination products:

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

r you and all expenses incurred on your behalf.

WHAT WILL MY ATTORNEY EXPECT OF ME?

The attorney will expect you to:
1. Be prompt for court dates and appointments;
2. Let him or her know how to keep in touch with you. If you have a change of address or phone number or place of employment, let your attorney know; and
3. Be completely honest -- even if it is embarrassing to tell the truth about your problem.
Remember, what you tell an attorney in private w

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

ill be kept confidential. Even confessions to past crimes or criminal activity are going to be treated as confidential by your attorney. Exceptions to this rule of strict confidentiality are plans for future crimes and continuing criminal activity or if the attorney believes that you have or will cause injury to a child. Attorneys are required by law to report suspected child abuse.
4. Not withhold any important information during the conversation that could be potentially damag

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

ing to your situation. A common tactic is for the other party to discredit you. Therefore, it is crucial that you fully disclose anything you can think of that could be used against you later on in the proceedings. Understand that even with the weight of the facts on your side, the situation could change if information comes out later that gives the advantage to the other party, because this information was not disclosed earlier to the lawyer.

HOW MUCH WILL THE ATTORNEY CHARGE

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

ME FOR HIS OR HER SERVICES?

The attorney’s fee depends upon many variables, such as amount of time, the difficulty of the work, the skill required, the customary fee in your area for similar work, the experience, reputation and ability of the attorney, and whether the fee is a set amount or contingent on the outcome of the case.

Some examples of fee arrangements include:

Flat fee: The attorney may quote you a set amount or standard fee that he or she has arrived at fo

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

Professional from academic institutions, pharmaceutical industries, health care indust

your type of legal problem. An example of a legal problem that could be covered in a flat-fee matter is an uncontested divorce without children or a simple will. In addition, lawyers usually expect you to pay court costs and to reimburse them for out-of-pocket expenses, such as travel, long distance, postage, courier, or copying expenses. It is important that you find out what any fixed fee covers.

Hourly fee: An attorney may prefer to bill you by the hour and collect an initia

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

l retainer. Such fees may vary widely depending upon the complexity of the legal work, the skill of the attorney and whether there are time deadlines. If you agree to an hourly arrangement, you and the attorney could include a provision in your contract requiring the attorney not to exceed a specified amount of time or money without obtaining your permission. Insist that you be kept advised every month of the number of hours that the attorney is spending on your problem. You also have

.

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

the right to ask for a written explanation of what the attorney did during the hours he or she worked on your case.

Questions about fees that you may want to ask are:
1. Can you give me an estimate of how much this legal matter will cost?
2. Can we have a written fee agreement that sets forth not only my obligation to pay you, but also exactly what services you will provide?

HOW SHOULD I MAKE MY DECISION TO HIRE AN ATTORNEY?

Based on your first interview,

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

Companies that provide selfless information through particip

you should consider the following factors before agreeing to hire an attorney:
1. Could you communicate effectively with the attorney?
2. Was the attorney clear and easy to understand?
3. Are fees reasonable in comparison with other lawyers’ charges?
4. Did the attorney give clear explanations of how he or she will let you know about progress in your case?
5. If you are not satisfied with this attorney, do not hire him or her. Look elsewhere for legal help

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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