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Top Articles - Are Regulators Trying to Set Prices?
Is The Securities and Exchange Commission trying to regulate price control? It appears that they are a
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
s they develop more rules and regulations on how the securities industries may charge their customers a
; 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
d the type of disclosures that must be made. Is it really the SEC's job to regulate prices? What happ
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ned to free markets and why should the government intervene in something they clearly do not understand
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
Although the rules and regulations have changed at an alarming rate in the last four years since Sarb
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
nes-Oxley they can't keep up with all the new changes that the industry is making in the marketplace no
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 should they try. When they make one rule all they have really done is given them selves job security
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
to keep making rules upon the rules that they have already made.
We need de-regulation of the securiti
We need de-regulation of the securiti
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s industry because the overregulation, which is destroying our markets. It is inciting too many lawsui
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
s and now there are too many lawyers in the boardrooms and accountants that are making the decisions ra
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
her than the decision-makers and executives of the companies.
If public companies are beholden to the
If public companies are beholden to the
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
shareholders and of course their customers and the labor and the regulations and the accountants and th
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
lawyers then everything they do is a giant compromise and therefore this is why they cannot compete in
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
world markets. The decisions made do not serve anyone since they attempt to serve everyone to no avail.
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
Most of these issues such as outsourcing, off-shoring, corporate malfeasance and the stock market drop
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
have been caused by government regulators and these are government regulators who have never had to mak
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
e a payroll in their entire lives. In fact they are borderline socialists and they have no business ru
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ning a capitalist nation or being engaged in the regulation of free enterprise.
I certainly hope this
I certainly hope this
.
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
rticle is of interest and that is has propelled thought. The goal is simple, to help you in your quest
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
o be the best in 2007. I thank you for reading my many articles on diverse subjects, which interest you
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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