Summary - Relationships

“Stand by your man,” the song goes. “Love him and be proud of him for he is just a man.

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

” ~ Tammy Wynette and Billy Sherrill

Remember Jackie O. and President Kennedy and more

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

Examples of combination products may in

recently Hillary and President Clinton? Despite being public humiliated, they stood by

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

their man. Stand by your man, especially in public. He may have done something wrong, i

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

n which case, chances are he will regret it if he hasn’t done so already. Support him b

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

Combination pro

t have a good conversation when you have a chance. This is a gesture that will be forev

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 appreciated.

Public disgrace and humiliation are already devastating without the ag

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

ravation of having you turn your back at him or put him down in public. The scene that

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

always comes to my mind is the one when Marilyn Monroe sang “Happy Birthday” to JFK at

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

is 45th birthday party.

It was such an obvious teaser, and done on purpose, too. Peopl

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

e were laughing. Even he looked embarrassed. And his wife was smiling and pretending sh

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

Following aspects would a

e enjoyed the truth of her husband’s indiscretion being thrown at her face. I bet she w

dd to the challenges in developing combination products:

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

s devastated inside. Nevertheless, she stood by her man and smiled to the very end of t

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

he provocation.

Now, if that isn’t class, I don’t know what is. Though no one is to ju

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

ge the whole affair, it is certainly that, in the public eye, Jackie was a winner. Situ

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

ations like this, perhaps in much smaller scale, happen all the time. It is good for a

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

Professional from academic institutions, pharmaceutical industries, health care indust

an to be supported by his spouse, at least until they get home.

A Word of Advice:

Lad

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

ies: Hurt inside, but keep your class. It is infinitely better to face misfortune stand

.

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

ng up, than retaliate dragging on the floor.

Gents: Avoid situations which can be publ

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

Companies that provide selfless information through particip

icly humiliating for you and consider yourself fortunate when your spouse stands by you

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 - Know Your Man: Being on His Side

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