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Write You - Nearly a Week of 112-115 Degree Heat Hampers California
California saw its worst heat wave in 10-years killing some
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
126-130 people. The heat wave produced record temperatures 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
f 112-115 degrees for nearly a week straight. Most of the de
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
aths occurred with elderly folks and some are wondering if t
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
here may have been a way to save more of these people in the
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
next heat wave? Is a new policy needed for heat waves to pr
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
otect people and elderly?
If you will recall the 1995 Illin
If you will recall the 1995 Illin
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
ois heat wave then you will recall that many new changes occ
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
urred in policy after that disaster. The United States is no
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
t the only place these heat waves occur and they kill many p
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
eople each year on different places around the Globe. It see
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
ms there needs to be a new plan of attack to deal with heat
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
waves. This plan needs to be perfected and given to the worl
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
d to further modify with regional variations to protect inno
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
cent human life during ominous heat waves.
Recently in Fran
Recently in Fran
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
ce many thousand people died from a heat wave and this did n
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
ot need to happen. The human race can do better this and we
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
need to make this a priority, as it will also open doors fo
.
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
r diplomacy and help unite us in a humanitarian common cause
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
to deal with heat waves. Please 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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