Others - Writing and Speaking

Writing is one percent inspiration and ninety-nine percent perspiration. For most writers, once you have the idea in your head, your muse takes over and you are off writing. After you finish you edi

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

t and polish until you are ready to send it out to editors. If you only submit a few manuscripts a year, your memory is probably enough to keep track of them. If you are a prolific writer, you will

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

Examples of combination products may in

eed a little more help.

A submission tracker is a great way to keep a record of each submission you have sent out, what ones were accepted or rejected and what you were paid by for your story when

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

t is published.

Before creating one you will need to think about how you want to keep track of your submissions. Are you a paper and pencil kind of person, or do you prefer to be computerized? Do n

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

t set up a tracker you will not use.

Paper submission tracker

Some writers prefer to use paper when writing and keeping track of their submissions. While they have to use a computer to type

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

Combination pro

up and print their stories; their creative juices flow through pencil to paper. If you are one of these writers, you need to decide what kind of book you are going to use to keep track of your subm

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

ssions. There are many different kinds of blank books you can use: loose-ring binders, spiral notebooks, bound books or file folders with loose sheets of paper.

Once you have your book you will nee

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

to start organizing it. The easiest method is to go alphabetically by titles, with each story or poem on one page. The best book for this is a loose ring binder, but you can use any book if you jus

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

remember to leave blank pages between the submissions to allow for new pieces.

At the top of each page, write your story or poem's title. Then divide the page in half. Divide the left side of 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

page into four equal columns. The right side of the page does not get split.

Next title these columns, left to right, magazine or publication, editor, date sent, reply received and comments. When y

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

u send your story out, fill in the first three columns, plus write the magazine's reading time in the comment column, so you will know when you should follow-up on your submission. When your story c

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

Following aspects would a

mes back, fill in the last two. You should always include the date you received the manuscript back and any relevant comments from the editor in the comments column. That is why it is the largest co

dd to the challenges in developing combination products:

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

umn, so you can keep track of what an editor says about your work.

This book is something you should check regularly. If you send out a lot of work, you might consider checking it weekly, depending

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

on how many submissions you have out there and the read time for the magazines.

You should also mark when an editor is slow in responding in your comments column. If your requests for status go un

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

eeded, mark that down. If they take twice as long as they say they will, write it down. Likewise, if a submission is returned faster than expected, write it down. Use these comments to decide if and

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

when you will send your next piece to them.

You can have one submission book for all your writings, or have one for each kind of work you do. It is really up to you.

Computerized Tracker

I

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

Professional from academic institutions, pharmaceutical industries, health care indust

you prefer to work off the computer, you can set up your submission tracker using a spreadsheet program. Create the columns like for a paper one. Remember to save it using an easy to find file name

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

.

There are several advantages to using a computer to track your manuscripts. One is you are not hampered by the size of the page when it comes to how much information you can put about your submis

.

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

ion. The other is you can sort your submissions easier than with a paper one, even changing what you sort by. But in the end it still depends on what you are comfortable using.

Writing is what writ

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

Companies that provide selfless information through particip

r's do best. Keeping track of what they have written and where should not be a lot of work. It just takes a little work and organization and you will be tracking your submissions like a professional

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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