Just Answers - Writing and Speaking

Well here we go. This is going to be the twentieth and final excerpt in my series on how to write a novel. Go ahead and copy these lessons or save them however you w

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

ant. I will leave them on line until I am finished with my eBook and then pretty much exactly what you are reading right now will cost. I wanted to offer my advice f

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

Examples of combination products may in

r free at first because I want people to feel the same passion for writing that I do and feel the tingling inside your body after you finish your first novel.

96. Do

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

This Properly

You have to go out and get a Fed Ex package and get ready to send your book out. Make sure you’re not sloppy about doing this. Take the time to make s

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

re everything is sealed up properly. Make sure it is all squared up. This package is going to be the first impression that a would be agent is going to see and if do

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

Combination pro

e sloppily things could go wrong for you right off the bat.

97. Give Your Novel Away

Okay whether you believe it or not the next step was the hardest one for me. I

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

had to give my book away to someone I didn’t know. Remember this was my first book. It almost felt like I was giving one of my kids away. But you have to trust Fed

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

Ex. After all this is what they do. Make sure you keep your receipt. Now you may as well forget about your novel because it is very, very rare that you ever hear an

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

thing sooner than 2 months.

98. Kind Of Fun

You have worked hard to get your novel written and submitted so now you can have some fun with it. It’s time to relax a

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

d let your hair down. Go ahead and have a drink or something and think about the future of your book. Imagine that it gets picked up for a movie. Start thinking abo

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

t which famous actor is going to play the lead. Think about who is going to play the other parts. Just remember this is all in fun but in life you have to allow your

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

Following aspects would a

self to dream.

99. Just Forget About It

Remember you have to wait at least two months and in several cases you will wait longer for a response if one even comes. D

dd to the challenges in developing combination products:

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

not even think about doing anything before two months. If after a couple of months you haven’t heard anything then by all means you can send a short letter to the ag

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

nt. I do mean short. Make sure it is just an inquiry letter and not something that is going to look like your pleading your case.

100. This Sucks But Its Normal

R

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

jection does suck but you have to turn it into positives. At least you know your work is getting looked at. Follow through on the suggestions that most agents will s

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

nd with rejection slips. Don’t forget that most of the famous authors out there were rejected numerous times before their works were published. If you take it person

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

Professional from academic institutions, pharmaceutical industries, health care indust

ally then I can guarantee that your writing career is over so instead of pouting while you are waiting go ahead and start your next novel. You will be surprised how m

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

ch easier the next one will be to write.

Well now it is time for this series to come to an end. I hope everyone has enjoyed it and even more I hope you have started

.

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

sing it. Please keep watching for more writing tips from me. I will be doing a couple of more long series but I will also be doing a lot of shorter How To Write less

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

Companies that provide selfless information through particip

ns on several different topics. So now I will sign off and let you get you novel going. Remember you write for yourself first and everybody else second.

Dale Mazure

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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