Advice Pool - Reference and Education

You’re young and strong and have the financial means to build your own house

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

. You have a truckload full of tools and some experience with a hammer, so

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

Examples of combination products may in

you think, “hey, I’m going to build my own house and be my own Contractor.”

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

Admirable if not enviable, but if you plan to use that experience in the at

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

tempt to one day getting your own contractor’s license…you can pretty much f

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

Combination pro

orget it.

Yes, it may take you ten to twelve months to build your dream hou

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

se, and you may have done some, most, or even all of the work yourself. But

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

a house built does not a contractor make.

The basic requirement to qualify

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

for a California contractor’s license is four years of experience at the jo

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

urneyman level. In order for someone to qualify for a license using only own

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

er/builder experience you would need to build twenty or more homes a year, f

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

Following aspects would a

or many years. That would be near to impossible for an owner/builder to acco

dd to the challenges in developing combination products:

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

mplish. Additionally, most people who want to use owner/builder experience r

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

eally only have limited experience because they have sub-contracted out part

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

s of the project. So if you were to submit that ten to twelve months of expe

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

rience to the Contractors State License Board you would likely be awarded th

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

Professional from academic institutions, pharmaceutical industries, health care indust

ree to four months of total experience.

The documentation required when sub

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

mitting that owner/builder experience and the poor return you’d be given for

.

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

your hard work, is why I would suggest not using owner/builder experience i

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

Companies that provide selfless information through particip

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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Advice Pool - The Pit-Falls of Owner/Builder Contractor Experience

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