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Digg It - What's the Secret Code?
As a youngster I loved reading spy / adventure novels. They were always exciting and adventures
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
ome. In most of them there was a “secret code,” used to communicate without fear of “the other
; 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
side” being able to decipher communications and understand what was transpiring.
I have observe
I have observe
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
d that, in many businesses, a “Code of Conduct” is also a “secret code.” When I hear a business
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
person say, “They should know that’s not the way we do things here” I ask whether they have a wr
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
itten policy regarding that issue. I might as well ask if they have a process for creating gold
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
from water so I guess that the way they want their company to perform is a secret. Few small a
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
nd mid-size companies have defined professional and performance standards for the company and it
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s staff. Yet all employees need (some even seek) standards that define boundaries and ethics.
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
If a “Code” is a secret and not defined, employees will individually set standards on their own
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
resulting in chaos, uneven delivery of service, and efforts working at cross-purpose.
A “Code o
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
f Conduct” can be defined starting with a definition of “The Ideal” (The “Ideal” way we greet cu
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
stomers, the “Ideal” way we fill out our time cards, the “Ideal” way we bag the groceries, etc.)
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
and commit the “Code” to writing.
Having a “Code” demonstrates that management cares about the
Having a “Code” demonstrates that management cares about 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
people and the work culture, affects retention and productivity, creates a climate of unity whi
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
ch establishes trust, and allows the guidelines to manage rather than management micro-managing
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
everything.
I lost my taste for spy / adventure novels as I matured and found other interests m
I lost my taste for spy / adventure novels as I matured and found other interests m
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ore exciting. As a business matures it finds that managing by system (A written Code of Conduct
.
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
is just one part of that system) allows the company time, energy, and resources to continually
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
move forward based on higher staff performance and the ever higher expectations of the customers
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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