Write You - Writing and Speaking

Success is the ability to go from one failure to another with no loss of enthusiasm. - Sir Winston Churchill

If you are in the freelance writing business, one sure thing that you

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

will face is rejection, which might feel like failure. If you have been in the business very long you have probably sent out numerous inquiries only to be met with silence, or ev

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

Examples of combination products may in

n worse, those candy sweet letters of rejection. Many writers find that in their early days as a writer that 9 out of 10 inquiries will never bring about anything, and for some, t

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

his can be disheartening.

The key to becoming a great freelance writer as opposed to only a decent one, is your ability to take rejection and make it work for you. What Winston C

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

urchill said is true - it truly is how you take failure that leads to your success. As a writer you need to be able to keep the passion for writing, even in the face of a rejectio

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

Combination pro

or a piece of writing that just fell flat. When you are rejected and when you fail - try harder.

One example of this comes from when I first started out on my own as a freelance

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

writer. I had enjoyed writing all my life and had been published from time to time, but I never took up writing as a career. I dabbled in a few careers such as the medical field

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

working in the ER, a nursing home, and home health care), the music field (traveling with a music group for 3 years playing the piano and singing), and also as a teacher (teaching

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

writing, music, and public speaking). Finally some health issues became a part of my life and I had to leave the formal workplace and I was looking for something to do to earn an

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

income. I could not stand just sitting around feeling sorry for myself, so I took something I enjoyed doing and started to look for ways that I could use it to make a living.

Whe

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

I first started out pursuing a career in freelance writing I wrote for pennies and sometimes nothing at all. My big break actually came after one of the most discouraging failure

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

Following aspects would a

s that I ever had. I had been asked to write a series of dance articles and I wrote my first one (which you can read if you ask me) and turned it in to the person I was writing fo

dd to the challenges in developing combination products:

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

. The article had become part of me and it was filled with passion and opinion, and the next day I received it back in my email with a note that it was too opinionated and that th

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

ey were going to get someone else to do the job. It was so frustrating because I had spent hours on that article, and in essence it had become a part of me, but I decided that no

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

atter what they said I was going to get that article published. I sent the article to a dance magazine and they loved it and published it, and that is when my freelance writing ca

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

eer really took off.

That rejection, and what felt like failure, was the point where I decided that I was going to make it as a freelance writer. I brushed myself off and got up

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

Professional from academic institutions, pharmaceutical industries, health care indust

and kept going and that one article opened up a variety of doors for me in the freelance market. You see, freelance writing is about more than just writing about certain topics, a

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

d it is more than just a way to earn some money, but it is a passion that you need to have in your soul. When it seems like everything you are trying to do might fail, you need th

.

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

at passion to back you up - to keep you from throwing up your hands and quitting. When you get that next rejection letter and you feel like quitting, remember that it could be the

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

Companies that provide selfless information through particip

very key to your success. Your failures are what will bring you success in life if you can handle them with enthusiasm and with a steadfast determination that you will not give up

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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