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So I tried writing some of my own emails. And these were bad emails. I am not much of a letter-writer. I do not write long

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

emails, as you may be able to attest to if you have ever asked me a question online. I answer the question. Period. If 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

u have thanked me for something, I rarely say ‘you’re welcome’ – if you have criticized me, I probably have not responded eit

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

her – but I answer your question.

I just believe in efficiency and writing letters and emails does not feel efficient to me.

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

Of course, I know that they are the most efficient way I can communicate online, especially when I have 6000+ people who ha

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

Combination pro

ve asked me for information at some point or the other. Actually it is more like 10,000 people who have actually asked me fo

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

r information, but only about 6000 who continue to care to read my stuff. Why? Some people don’t like my style. And that i

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

s ok with me.

You see, if everything I wrote made everybody happy, I am probably doing something wrong. Why? Because some p

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

eople are doing things wrong online, they are not making money online. Some people have been online for 5 years and have not

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

yet made their first $100. Some people have been online for a year and have only made $5000. I have been online for 8 mont

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

s and have made over $45000. Each month I now do over $11000. That is $132,000 in annual revenue, and of course each month

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

Following aspects would a

that number should go up. So I am going to say some things that make some people mad. Why? Because I don’t do things the w

dd to the challenges in developing combination products:

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

ay they do them. If I did, I would have their results.

It is kind of like driving a car. If you drive 30 miles per hour, i

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

t is going to take you 2 hours to get to a destination that is 60 miles away. If I get in the car and drive 30 miles per hou

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

r, I am going to get the same result – it is going to take me 2 hours to get to the destination.

But if I get there in 1 hou

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

r instead, what do you know? You know, instinctually, that I have driven differently than you have. It is simply a fact – a

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd you know it in your gut. Now if I tell people how I am able to get to that destination in half the time, some people are

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

going to get upset. And that is ok. I am comfortable getting there faster.

And your emails are going to be much the same.

.

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

You can get there faster than other people, if you know you to do it, if you know how to drive faster. And that is exactly

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

Companies that provide selfless information through particip

what I am going to do in this section – I am going to teach you how to drive faster. I am going to teach you to drive better

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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