Useful Advices - Business

Does it turn you off when you’re introduced to someone by your given name and few seconds later that person addresses you by the wrong name? Tom rather than Tim? Or June instead o

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

f Jane? And then, in an obvious attempt to commit your name to memory – the wrong name, that is – that person repeats the error several times more?

While most of us are too polite

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

Examples of combination products may in

or too timid – to correct that person, their continuing the error can make you want to shake him or her by the shoulders and say, “Hey, can’t you get it right?”

Being on the receiv

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

ng end of an error-riddled written document, no matter what kind or from whom, can have the same effect: “Hey, can’t you get it right?”

There’s no excuse for sloppy grammar, punctua

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

ion or spelling. Reasons, perhaps. But not excuses. Nothing can or does excuse such errors.

The one reason I’ve run into most often seems to originate with members of the under-4

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

Combination pro

crowd. When it comes to the rules of proper grammar, punctuation and spelling, I believe if they were taught at all, those rules were seldom reinforced.

Forgive me if it seems lik

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 I’m picking under-40 generation – that’s not my intent – particularly since it’s not their fault. But let me share with you one of countless true stories I’ve heard supporting tha

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

belief.

Some 20 years ago, when a sophomore in high school, a young man came home one day, proud as a peacock, with a science paper on which, at the top of the page, in red ink, hi

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

teacher had written and circled a big “A.” Under that circled “A” the teacher had written “Great Work!”

He and his parents, both friends of mine, knew that an “A” in science was n

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

easy accomplishment. Certainly not from this particular teacher who had a reputation for being demanding. Science, after all, is a rather precise field of study.

The young man’s

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

ad, also a writer, proudly began reading his son’s “A” paper. Then he did something instinctively, something he should not have done. He began mentally ticking off the spelling, gr

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

Following aspects would a

ammar and punctuation errors in his son’s paper. As he finished the first page, he looked up at his son and asked, ”How can this be an ‘A’ paper with nine errors just on one page.?”

dd to the challenges in developing combination products:

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

The son, as you might expect, answered his dad defensively, “Because that stuff doesn’t make any difference.”

Puzzled, the father asked “And why not?” to which his son responded, “

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

ecause my science teacher doesn’t care about spelling or any of that other stuff. That,” he said pointing at the paper in his dad’s hand, ”is a science paper, and I got all the scie

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

ce part right.”

Regardless of whether you’re under or over 40, life in the real world isn’t as forgiving. Everything you write in the real world is a reflection of who you are, wha

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

you know, and what your values are, of what you’re capable of doing and being. That’s particularly true in the real world of business.

While sloppy grammar, spelling and punctuati

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

Professional from academic institutions, pharmaceutical industries, health care indust

on may be overlooked by a friend reading a casual letter or email you’ve written, that’s not going to happen with your business letters. Such errors there have at times been known t

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

be “fatal” because they’ve changed the original intent of the document.

Errors are particularly significant in the emails you write because emails can take on a life of their own.

.

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

They’re often forwarded to people you may not have met – in fact, may never meet – people who, based on your poorly written email, form a lasting opinion about you, perhaps even deci

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

Companies that provide selfless information through particip

e your future.

The bottom line is that regardless of which side of 40 you happen to be on, if you’re gonna write, whatever you write, write right. Or should I say “write correctly?

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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The DA0 record for medical billing of claims electronically, is one of the longest records. We continue our review of this record with fields 8 through 16.

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