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Top Articles - FAA to Regulate Space Flight and Space Ships?
Well it seems the Federal Aviation Administration seems to have more lofty goals
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
than the new NASA Mission to the Moon and Mars. The FAA now wants to regulate Spa
; 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
ce Flight in the entire Galaxy and the Universe and probably all 13 dimensions? A
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
nd the Lawyers are loving it as they see a new market as well to sue people in. Y
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ou can bet lawyers will find a way to sue the up and coming new Commercial Space
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
Ventures.
The Federal Aviation administration has been making rules and stifling
The Federal Aviation administration has been making rules and stifling
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
free market innovation for far too long. Like any BS bureaucracy, now the FAA wa
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
nts to expand to become the “Inter-galactic Regulatory Federation Star Fleet Comm
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
and Rule Makers” and to boldly put rules and regulations where no man has gone be
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
fore. Some might laugh at all this, but it is not funny, who do you think is goin
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
g to pay for all this rule making; us, the taxpayers.
This is your fine governme
This is your fine governme
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
nt at work stifling a fledgling industry as it is just getting off the ground. Se
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
tting up barriers to entry rather than letting free enterprise work out the bugs
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
first. We cannot trust regulatory bodies, as all they do is make rules to help la
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
wyers sue and thus turn over entire industries to the sharks. We must tell the FA
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
A to take a hike and clip their wings, they are not serving the forward progressi
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
on of the species. They more resemble lead weights attached to lightweight high-t
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ech material, which will be needed to press on. Any Politician worth their salt w
.
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
ould tell the FAA to stick it and do what best and right by the American People a
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
nd the future of innovation and commercialization of space. Think on 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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