Actual - Writing and Speaking

Often the hardest part of writing is getting started. Even the best writers sometimes get stuck and struggle to put the first word on paper. Sometimes the project feels overwhelming. You can make the p

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

roject more manageable by breaking your project into pieces.

First, get a pen and paper (or sit down at the computer) and make up your mind to do a brainstorming sessions with yourself. No matter who yo

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

Examples of combination products may in

are or what you do, you have information that other people want to learn. Choose one or two topics that interest you, and write down key words that pop into your mind when you think about the topics. Fi

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

l up the page and write quickly. Don’t stop to edit or change what you write. This is a good way to get your creative juices flowing.

Now look at each word you wrote, and expand on each word to explain

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

r give examples. Again, just write anything that that comes to mind that describes or explains the words you wrote. Add any information or stories that adds interest to what you write. You still don’t

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

Combination pro

eed to stop to edit what you write.

After you have completed these two steps, stop and look at what you wrote, and you will find that you have written more than enough to create an article. It’s time to

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

edit now, but don’t question or second guess what you wrote. Just organize what you wrote to make your thoughts flow sensibly and make your writing easy to follow.

Try to write an introductory sentence

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

or paragraph that gets the reader’s attention. Sometimes you can do this by asking the reader a question or giving them a statistic that illustrates the points your article will make. The next paragraph

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

will explain your ideas and demonstrate the topic of your article.

It is always best to use simple, direct language that a 12-year-old can understand. Do not use long, complex sentences. Describe the

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

opic and explain how it works or why it happens. Give examples, describe solutions, and explain why this information is important to the reader. Also, tell you readers where to find additional informati

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

n on the topic.

It is time now for the most important step – edit and proofread. Use spellcheck, print your article, and read it several times. If you can, it is always a good idea to have someone else

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

Following aspects would a

read your article to check for typos and be sure it makes sense. After your article is complete, the fastest and easiest way to get it published is to find an online publisher.

It’s best to find a plac

dd to the challenges in developing combination products:

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

to publish that you think will attract your potential clients. The online articles are called “ezines,” and there are many sites that publish ezines free of charge. However, they do not pay for article

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

, but your article will reach thousands of readers. Just “Google” ezines or publish articles, and you will find many web sites that are actively looking for new articles.

You may want to include a list

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

f your published articles (ezines) on your website and offer to send free copies to anyone who asks. This will give you something of value that you can offer to anyone who visits your website, and it wil

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

give you contact information for the people who visit your website. Once you get over the fear of writing, you may find that you enjoy it, and the articles you publish will give you confidence and good

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

Professional from academic institutions, pharmaceutical industries, health care indust

exposure. Also, you can accurately state that you are a published author.

Jo Ann Joy, Esq., MBA, CEO
The future of your business starts here!

You may contact Jo Ann by phone at (602)

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

663-7007, by fax at (602) 324-7582, by email at joannjoy@Indigo Business Solutions.net, and by mail at 2313 East Ocotillo Rd., Phoenix, AZ 85016. I have many published articles, and I will send an

.

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

article to you free of charge. Most consultations are free.

For information about other important legal, tax, and business topics, free copies of articles, or EBooks, please visit our website at

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

Companies that provide selfless information through particip

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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