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Answers - Aircraft Washing and Regulatory Issues
Perhaps you are a pilot or just love aircraft and you want to start a b
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
usiness washing, cleaning and detailing general aviation aircraft such
; 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
as single engine, cabin class twins and private or corporate jet aircra
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ft? There will be things that will be required of you by the local airp
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ort in order to get an activity permit, as well as some regulatory issu
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
es.
Should you build your own aircraft washing unit? Well, if you buil
Should you build your own aircraft washing unit? Well, if you buil
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
d your own unit, you will need a way to remove the water from the ramp,
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
as most Airports have NPDES Permits of what storm water is allowed to
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
leave. Even though it is full of Jet A and de-ice fluid run off, they s
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
eem to go over board to regulate aircraft washing? Silly I know? But re
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
alize the EPA is a little insane anyway? I am sure they will tell us we
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
cannot breath the air, because it is regulated by the FAA and the EPA
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
says it has contamination from the Chinese Dust Storms or an Indonesia
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
Volcano?
Between the EPA and the FAA you have to at least understand w
Between the EPA and the FAA you have to at least understand w
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
hat you will be dealing with. One person told me that he read on 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 website that the FAA now regulates aircraft washing, well this is sim
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
ply not so, and if the FAA website states this, well then the FAA site
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
is in error, basic washing requires no licensing. I am sure someday tho
.
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
se blithering idiots might attempt to control more that which they do n
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
ot understand. Such as Private Space Flight? 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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