Actual - Legal

I get a lot of calls to my office about legal documents. Most times the calls are about Last Will and Testaments, Living Wills, Powers of Attorney, Buy-Se

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

ll Agreements and such. The prospective client always asks the costs for drafting such a document and then after I respond the inevitable question arises.

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

Examples of combination products may in

Why can’t I just go online and use one of those documents? So and So website sells a Last Will and Testament for $19.95. My response? Go ahead, be my

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

uest, just don’t complain when you find that the document has errors or is invalid in your state.

I have found that many of the legal documents online are

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

general, vague representations of what a truly finished legal document should be. What you need to understand is that each state has different laws and d

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

Combination pro

fferent requirements for a document to be legally binding. In Pennsylvania, for example, a Will typically requires two witnesses to be valid (there are ex

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

ceptions to this rule, but that is for another article). In Florida, under certain circumstances, three witnesses are required for a Will to be valid. Yo

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

u might not know that if you didn’t consult with a Florida Attorney regarding those requirements. The problem that I have found with various online docume

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

ts is that they try to apply to all states at once, in a general fashion, and fail to consider the individual requirements of each specific state.

This is

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

not to say that all online legal documents are invalid. To the contrary, some of them are very well written and serve to protect your interests fully. T

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

e question is, how do you know if the document is well written and valid? The answer: You don’t. You are not an Attorney and you haven’t gone to law scho

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

Following aspects would a

ol, that was the reason that you called the law office to begin with. You also likely had the same doubts that I am expressing about online legal document

dd to the challenges in developing combination products:

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

s or you never would have called an attorney in the first place.

Think about your underlying need for a legal document. Perhaps you were considering havi

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

g a Last Will and Testament drafted. Why do you want one? Likely, it is to ensure that your estate is settled properly and that your assets are distribut

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

ed to the heirs of your choosing. That’s a pretty important reason. Should you trust something that you found online at a discount and hope that it is va

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

id? I’ll let your common sense answer that question and hold back my own answer for another time.

Perhaps you are considering adding a new salesman to yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

ur sales force. Your company has sensitive and valuable information and clientele, so you ask the prospective employee to sign a Covenant Not to Compete.

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

You can find a form for that online with a few clicks of the mouse. The question is whether you want to trust such an important undertaking to what you

.

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

ind at a random online website. If you do, be my guest. If you want to ensure that the document is drafted to meet the requirements of your state and wil

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

Companies that provide selfless information through particip

l wholly protect your interests, contact your local attorney. If you are concerned with his/her prices, simply get out the phone book and call another one

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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