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Answers - Wills
A will is a legal document that determines what happens to a person’s property after his or her
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
death. A will states who receives property and assets and in what amount. Property distributed u
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
nder the terms of the will become the probate estate. Making a will is a responsibility, as well
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
as a right that is protected by law.
A will should be made when a person is legally competent,
A will should be made when a person is legally competent,
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
having a sound mind and at least 18 years old. It should be prepared while its maker is in good
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
health and free from emotional stress. In other words, to make a valid will, people must underst
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
and things such as what property they own, its value, and whom they are leaving it after their d
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
eath.
A person does not need to have a large estate to plan and prepare a will. Anyone who owns
A person does not need to have a large estate to plan and prepare a will. Anyone who owns
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
property, including cash, stocks, jewelry or furniture, or real property, such as land or house,
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
could prepare a will. If married, each spouse should have a will indicating the ownership and t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ransfer of property.
In addition to distributing or transferring of property, a will should hav
In addition to distributing or transferring of property, a will should hav
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
e other functions. It may be used to name a guardian for any minor children or to create a trust
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
and designate a trustee to handle an estate (property left after death) on behalf of children or
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
others. A will may also be used to name a personal representative or an executor to handle a de
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
cedent's property and affairs from the time of death until an estate is settled.
When there is
When there is
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
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
no valid will, the person is said to have died intestate. A court appoints an administrator to h
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ndle the decedent's affairs, and his or her property is then distributed according to a formula
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
fixed by law. After payment of taxes, debts, funeral expenses and administrative costs, the prop
.
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
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
erty goes to the surviving spouse, children or relatives. The laws are specific as to how proper
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ty is to be distributed, including which relatives have priority and how the property is divided
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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