Advice Pool - Relationships

In real life, law rarely forgives any wrong act. In most of the countries l

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

aw is clear about punishment. We still hear a lot about forgiving in person

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

Examples of combination products may in

al relationships. We are told to forgive the major blunders. We are asked t

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

forgive and forget and continue living as if nothing happened. Does that w

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

ork? To some extent yes, and to some extent no.

Most of us who have been h

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

Combination pro

urt in relationship don’t wish to forgive at all. The result is that we suf

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

er from the pain all our life. We are advised to forgive so that at least w

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

e can feel peaceful. If we don’t forgive, our own peace is lost forever and

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

we suffer. Forgiveness is for us. To forgive does not always mean that the

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

abuser can continue with the same behavior. You need not tell the abuser th

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

at you have forgiven him/her. Let them suffer for what they did. But by for

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

Following aspects would a

giving in your own mind, you get peace.

Relationship after forgiving - the

dd to the challenges in developing combination products:

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

relationship can never continue at the same level and intensity after any m

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

istake has been made. No amount of forgiveness can ever bring the relation

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

back.

Bringing relationship back - I have said earlier that no relationshi

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

will return to the same old level after a major mistake has been committed

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

Professional from academic institutions, pharmaceutical industries, health care indust

. This is true. But what if the partners want to bring it back to the old l

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

evel? How should they proceed? In this case, the abuser should ask for for

.

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

iveness again and again. Only after the victim is satisfied, the forgivenes

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

Companies that provide selfless information through particip

s can become effective to the extent that relationship comes back to normal

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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