Answers - Legal

It has not been easy so far has it? Facing up to our own mortality is not something we like to do regularly.

Nevertheless,

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 have done it, you have made your will. You have probably read also about Living Wills, which deal with your health and

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

Examples of combination products may in

medical requirements should you become seriously ill or suffer a serious injury.

You may also want to consider making arran

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

ements for your funeral. Some things to consider are-

# Pre-paid funeral plans
# Arranging a funeral without a funeral

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

director
# Donating organs for transplantation
# Procedure at the Registrar’s office
# Funeral payments from

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

Combination pro

the Social Fund and who can get them
# Bereavement Support organisations

Another often overlooked area for our conside

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

ration is 'Instructions for our next-of-kin and executors' on our death.

Imagine if you will, that you wake up one morning

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

and you have completely lost your memory. You cannot remember your name, your loved ones names, your bank details, your ins

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

rance details, your computer password, the newsagent who delivers your papers, etc, etc. This is often a similar situation

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

the relatives of the deceased find themselves in, at a very distressing time.

There are many details that need attention, s

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

me immediate and some later, but the point I am making here is, how could anyone be expected to know all those personal deta

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

Following aspects would a

ils about you, or even where to find them.

Whilst not a legal document, your instructions for your next of kin can save a l

dd to the challenges in developing combination products:

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

ot of stress and worry for your loved ones. Once complete, you can hand it to the relevant person to keep in a safe place.

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

The type of information outlined in this document is:-
# Your personal details.
# Where to find your will.
#

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

Your medical information.
# Contact details for the person you would like to arrange your funeral.
# People to con

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

act after your death ie friends and family, legal people, financial contacts, employer etc.
# Funeral arrangements.

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

Professional from academic institutions, pharmaceutical industries, health care indust

# Instructions for after the funeral.
# Where to find things ie, house keys, birth certificate, passport, insurance d

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

etails, deeds of house, bank details, credit cards, car keys and log book and so on.
# Where to find details of your fi

.

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

ancial liabilities.

All this information will save your loved ones hours of searching and stress.

Please remember, this is

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

Companies that provide selfless information through particip

not a legal document, it does not replace your will but nevertheless is a very valuable document for those you leave behind

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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