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Actual - National, State and Local Laws: Understanding the Game
So often folks starting out do not understand the game and all t
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
he laws, which they must deal with. Today we have an abundance o
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
laws and duplications in law at all levels of our government. T
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ese laws are in place so that we can run a cohesive society and
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ivilization. Indeed it appears to be working quite well, as toda
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
it is hard to dispute that the United States of America is by f
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 the greatest nation in the history of mankind.
Is there too m
Is there too m
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
ch redundancy in our laws in the United States of America? Surel
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
there is and few would deny that. The real problem is not with
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
uplication, but rather multiple jurisdictions with slightly diff
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
rent rules on the books making it tough on citizens, land-owners
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
and businesses both large and small. What can we do to fix thes
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
issues?
Well, perhaps we need to sit down amongst ourselves an
Well, perhaps we need to sit down amongst ourselves an
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
stop acting like the United Countries and start acting like the
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
United States that we are. In doing so it might be wise to have
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
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
similar set of laws which make doing business, traveling or any
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
hing else relatively simple. Maybe a red magic marker committee
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ight be a great idea and line out those laws, which are overly r
.
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
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
dundant or simply no longer make sense. Simplicity will save us
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
rom this maze of laws, if we allow it. Consider all this in 2006
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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