Top Adding - Writing and Speaking

“Sticks and stones may break my bones, but words will never harm me.”

You probably heard those tau

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

nting lines in grammar school, but do you really agree that harsh or negative words do not harm us? Words have

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

Examples of combination products may in

energy and power. Surely we have all had our feelings hurt by something someone said.

Our actual words may not

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

affect us as much as the way we interpret them and how we say them. Here’s an example:

An ancient king d

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

reamed all his teeth had fallen out. He sent for a wise man to interpret it: The dream means that all your re

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

Combination pro

latives will die and you will be left alone!

The king was furious and banned the interpreter from the palace.

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 called for another interpreter who said, “Rejoice, O King! You will live many more years. In fact, yo

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

u will outlive all your relatives. Long Live the King!”

Both interpreters gave the same interpretation

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

but there was a huge difference in the delivery given by each one.

While our speech must be understood by thos

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

who hear our words, the way we say things and the intention behind them have as much power as the words themse

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

lves. Body language, gestures, tone, and volume play a large role in the way a message is received.

Words can

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

Following aspects would a

arouse anger or elicit appreciation. Which would you rather receive?

The Golden Rule says, “Do unto othe

dd to the challenges in developing combination products:

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

s as you would have them do unto you.” Think of this when you are angry and want to lash out at someone.

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

Would you want the same treatment in return?

Imagine yourself as a radio tower. Through your words, you are em

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

itting radio waves into the air. People’s minds are the radios all over town receiving your message. What

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

kind of vibes are you sending them?

Gossip and slander have no purpose other than to harm. Because words with

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

Professional from academic institutions, pharmaceutical industries, health care indust

intent have energy they may have a detrimental effect even if no one hears them.

Have you ever known anyone wh

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

o is a naysayer? They always see the glass as half empty rather than half full. I’ve known people who w

.

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

uld pour out half the contents of a glass just so they could say that the glass is half empty. How do you feel

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

Companies that provide selfless information through particip

when you are around this type of person? Remember words have power. Use them wisely.

AWAY WITH NEGATIVE WORDS

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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What exactly is closing? Does it have to be the stereotypical high pressure tactics?

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