Top Articles - Writing and Speaking

Does it sound ridiculous to say that the magical key to unlocking writer's block is to write? After all, if you're bl

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

ocked, how can you write?

I understand how you feel. I've felt that many times. Can I emphasize "many times" enoug

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

Examples of combination products may in

? Each time I've been up against the wall, completely and totally blocked (and frustrated of course!) I knew the only

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

thing I could do was to write. Not the article, or story, or book I had been working on. Nothing flowed in that dir

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

ction. It was as if the tide had gone out and I could not bring it back. It would have to come back on its own. A

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

Combination pro

nd what is true is that tides do come and go. They ebb and they flow. I had to learn to get into the rhythm of the

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

ebb and flow. Certainly my writing ebb and flow was not as predictable as the movement of the tides, but reliable no

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

e the less. Keeping my hand moving helped to either pass the time or to bring the flow of words back into my mind an

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

onto the paper.

What is there to write when there's nothing to write? I found there was always something to write.

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

Sometimes I'd repeat a word over and over and over, until it morphed into some other word. Sometimes it would even

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

become a sentence. What a delightful surprise only too often to be met by the repetition of that sentence. Over and

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

Following aspects would a

over and over. But, with faith in the movement of the tides, I would keep writing that sentence. Often new sentence

dd to the challenges in developing combination products:

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

or new words would form. Sometimes I'd change the arrangement of the words or write nonsense words. Words like "nu

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

f" and "kalis" and even "megastopalis," just because I liked the sounds of them. Then there were words that were made

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

into nonsense from sense. Like "drows" for "words," and "nappeh" for "happen." Just because I liked the sounds of t

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

em. Sometimes words were even put into some kind of graphic design, like "b*i*g____a?p?p?l?e?!!" Just because I lik

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

Professional from academic institutions, pharmaceutical industries, health care indust

d the way they looked. Any kind of writing to pass time or help the words find their way back into the article, stor

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

y or book.

In time -- time has become my friend -- the words would move again in the right direction. It's necessar

.

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

to trust in the power of words, any words, on paper. Your paper with your pen. Or, your fingers on your computer.

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

Companies that provide selfless information through particip

Or your voice on your tape recorder. Because what is true is that as the tide goes out, the tide comes in. Always

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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