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How many popular sayings do know pertain to “respect?” I know you have heard, “to get respect, you have to give respect;” and “respect is

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

a two way street;” and “you have to earn respect;” and probably the most famous, “R E S P E C T, find out what it means to me!” Anyway y

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

Examples of combination products may in

ou slice it, getting and giving respect are ingrained formalities in American culture. Some people demand respect, some people never get

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

respect, other people give respect. Many different opinions exist regarding the importance of “respect;” however, you personality, work e

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

thic, and motivation will dictate whether you believe “respect” to be important.

Do you care if you get respect? Do you need to give res

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

Combination pro

pect to get ahead? Is respect important to your success? These questions have haunted many entrepreneurs during their journey towards su

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

ccess; however, the most important question you need to answer is, “does respect equal success?”

You will meet many different people duri

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

ng your entrepreneurial journeys. All of these people will have different beliefs about business, management, and experience. Some of th

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

ese people will question your abilities due to your age (young, old, or middle-aged), your appearance, and/or your gender. Some people wi

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

ll never give you the “respect” you feel you deserve, and some people will simply not “respect” you. In order to overcome these obstacles

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

, you have to believe that your success is dictated by your efforts and your abilities and not on the opinions of others. You have to KNO

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

Following aspects would a

W that YOU control your situation.

Does this mean that you should be disrespectful to anybody who you feel is disrespectful to you? Thin

dd to the challenges in developing combination products:

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

k about it like this; are you in this game to get revenge? Does the negative attitudes of a few affect you so much that you will put your

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

goals on hold to extract a slight feeling of power by “getting back” at somebody? Hopefully, you answered NO! Know that you are running

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

this race to achieve your version of success. If you stay true to yourself, respect will come. Do not try to change who you are to appe

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

ase the disrespectful few. Stay yourself, stay in control, and stay motivated, and you will get the “respect” for which some of you so di

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

Professional from academic institutions, pharmaceutical industries, health care indust

rely yearn.

So, is respect a two way street? Do you have to give respect before you can get respect? Respect the people who deserve you

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

r respect. If you want to “brown nose” to get ahead, entrepreneurialism is the wrong career choice for you. Entrepreneurs are the renega

.

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

des. We are the outcasts who refuse to work from nine to five in a small cubicle for peanuts. We are the people that are willing to risk

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

Companies that provide selfless information through particip

much in order to gain more. Keep this mentality, keep your motivation, and most importantly, keep your “respect” and success will follow

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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Are you still guessing on what's working or not? Forgotten what to track? Are you still making decisions without supporting data? why are you not following a simple process that works?

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Often you see job postings with a request to Send resume with salary history to... I don’t know about you but the first thing that pops into my mind is within what range do they expect to pay? The next question I ponder is whether or not it’s legal or any of their business. Who will see this information when my resume and accompanying documents are received?

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