Main Subject - Business

Have you ever been befuddled by words you don’t know – but think you should? Or overheard c

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

onversations you know you should not?

What if you are the offending party? In most cases y

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

Examples of combination products may in

u are not aware of being a boor. Note - according to the dictionary, a boor is a rude or

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

insensitive person – and geez, you might be boring as well.

Whether you are on the road, a

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

a trade show or in general business situations, here are 5 Quick Tips to help you watch

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

Combination pro

our language -

KEEP IT CLEAN –
You never know whom you will offend with sexist or racis

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

t jokes or remarks, a potty mouth or derogatory gossip. Client? Potential client? Employe

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

s? We expect situations to be neutral and we have long memories of those people who make

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

s uncomfortable.

WHAT is XYZ –
Every industry has its Jargon. There are inside-the-ind

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

ustry or company buzzwords, abbreviations and snippets of phrases. Sure, you know what it

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

means, but it could confuse new employees or clients. Can you explain the jargon in simpl

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

Following aspects would a

words?

WELL – DUH –
Select the five most difficult questions you have been asked. Pa

dd to the challenges in developing combination products:

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

ss them around the office. Find accurate, easy-to-remember answers.

I’M ON THE PHONE –

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

And everybody can hear you. When in public, is a phone call considered private? NO. If I c

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

n hear you I have no obligation not to listen. Personally, I have heard waaaay too much p

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

rivate and company information from cell phone yakkers. Like what, you say? So watch what y

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

Professional from academic institutions, pharmaceutical industries, health care indust

u say or it could snap back on you or your firm.

BE POLITE –
Rush, rush, rush – what

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

happens? Manners drop by the wayside and we expect everyone to understand if we are rude

.

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

or just seemingly disconnected. But we miss those nicities, they are the social lotion that

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

Companies that provide selfless information through particip

helps us through situations. So, say Please, Thank You, You are Welcome. We appreciate it

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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