Answers - Legal

The legal process of the distributing of the estate of a deceased individual is known as probate. Probate is often a time-

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

consuming and confusing process for those who are involved. Most people lack a knowledge of the probate process because of

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

Examples of combination products may in

inexperience with the process.

While probate is rarely easy, an adequate knowledge and understanding of the process can

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

decrease stress, and increase your confidence that everything is being done properly. Anyone involved in probate should un

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

erstand the following:

1 – In cases where a valid will exists, the individual named in the will as the executor is respon

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

Combination pro

sible to see that the deceased’s instructions are carried out.

2- In cases where a valid will does not exist, an individu

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

al will be appointed by the court as the administrator. The administrator will perform the duties of the executor.

3 – Du

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

ing probate creditors of the estate are provided with an opportunity to place claims for unpaid debt. The validity of thos

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

e claims is determined by the court. Any claims that are valid will be paid out of the estate.

4 – Probate court is the h

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

ome of the probate process. Laws and procedures vary from state-to-state. Some states have courts with the sole responsibi

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

ity of overseeing probate.

5 – Although the length of probate will vary, it will usually last for six months to one year.

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

Following aspects would a

More complex estates will typically take a greater amount of time.

6 – Inheritance cash advances are available for heirs

dd to the challenges in developing combination products:

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

to estates in probate. Cash advances provide part of the inheritance upfront and help the heir to avoid the long wait req

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

uired by probate. Please visit www.probate-web.com/inheritance_cash_advance.htm for more information.

7 – Certain assets

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

ay not be subject to probate. Retirement accounts and life insurance policies normally name beneficiaries, which allows 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 beneficiary to obtain ownership of the asset without going through probate.

8 – Proper estate planning can make it poss

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

Professional from academic institutions, pharmaceutical industries, health care indust

ible to partially or completely avoid probate. Estate planning is a priority for those who wish to ensure an easier proces

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

for their heirs and beneficiaries. For guidance in estate planning seek the advice of a professional.

9 – Real estate th

.

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

at is tied up in probate can be sold during probate, without waiting for completion of the process. If you have real estat

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

Companies that provide selfless information through particip

e that is currently in probate and you are interested in selling, please visit www.probate-web.com/probate_real_estate.htm

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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