Summary - Relationships

When we think of the kind of ongoing love relationship we wou

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

ld desire to live in, one of the things we think of is a sens

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

Examples of combination products may in

of warmth.

At the same time, there are times in love relati

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

onships when it can get quite chilly. When anger, resentment

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

nd other negative feelings have built up, the relationship ca

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

Combination pro

feel as cold as ice.

Once it gets icey in a relationship, w

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

e can either deepen the ice or break the ice.

How to deep

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

n the ice

=> Do your part to keep up the silent treatmen

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

. Believe it is healthy and useful.

=> Rehearse whatever wro

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

ngs have been committed over and over in your mind. Do not le

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

them pass.

=> Bring others into the situation and try to co

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

Following aspects would a

vince them you are a victim and your partner is a villain.

=

dd to the challenges in developing combination products:

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

> Take verbal shots at each other.

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

=> Take responsibility for your part in the mess you both
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ave created.

=> Be first - to apologize, break the silence,
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
break the ice. Being first makes you the bigger person. Take
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
he lead.

=> Agree that more than a few seconds of the silent
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
treatment is unacceptable.

=> Refuse to accept the silent tr
.

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
eatment as an option in the relationship.

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

Companies that provide selfless information through particip
e relationships are inevitable, remember that ice is optional

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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Summary - Relationship Advice: I is for Ice

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