Advice Pool - Relationships

Relationships are tough enough without all the reactivity

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

that comes with them. One of the situations in which it is

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

Examples of combination products may in

so easy to get reactive is when a request is made that you

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

do or not do something.

It occurred to me in a couples co

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

ching session today that there are at least three response

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

Combination pro

we can make to a request from our partner. We'll take a l

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

ok at the two negative ones and take a look at the winning

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

approach.

Three responses to a request

Compla

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

n - This is the worst response. I like to call it P &

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

, which stand for Pissing and Moaning, which is what a lot

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

of people do. Creates an atmosphere of tension, conflict a

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

Following aspects would a

d reactivity.

Comply - Better than complaining, bu

dd to the challenges in developing combination products:

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

not by much. We comply when we really don't want to do so

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

ething yet believe we have to or believe we should. Sets u

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

a "grit your teeth and bare it" kind of atmosphere.

H

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

nor - Sometimes when I want to explain what a word mea

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

Professional from academic institutions, pharmaceutical industries, health care indust

s I'll check out at dictionary.com, which tells us this ab

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

ut the word honor:

"high respect, as for worth, merit, or

.

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

rank: to be held in honor."

So when we honor the request

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

Companies that provide selfless information through particip

f our partner, we are demonstrating high respect and worth

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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Advice Pool - Relationship Advice: To Honor, Comply or Complain

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