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Populated by Native-American Indians, the name Pocono means ""stream between two mou

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

ntains,"" and rightly so, since the Delaware River runs between two mountains. The h

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

istory of the Poconos dates back to the 1800s where the first tourists stayed at boa

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

rding houses close to the riverside. Soon New Yorkers and Philadelphians made the Po

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

conos their little hideaway for vacationing with their family during the summertime

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

by the mountain lakes. Even World War II soldiers were reported to have gone to the

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

Poconos for rest and relaxation before leaving for combat overseas.

The Poconos hav

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

become such a favorite vacation hub that families have purchased second homes there

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

, just so that they can enjoy all that the resort has to offer. A visit to the Pocon

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

os is an escape from the monotony of everyday life. The area is built up with franch

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ise restaurants and major shopping malls, without sacrificing the unspoiled nature t

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

hat the mountain resort has become associated with. When it comes to having a good

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

time there, those who visit have lots to choose from, activities such as wildlife, b

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ird watching, horseback riding, fishing, kayaking and even golfing.

Most of all, vi

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

itors to the Poconos are enthralled by skiing down the mountains during the winter.

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

The Poconos experience four-season weather but some nights are undeniably colder tha

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

n during the day, even around spring and summer. The coolness of the breeze though,

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

is more than refreshing, especially to those who vacate their 70-plus degree summer

.

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

weather.

And if outdoor activities don’t excite you, there are local wineries and b

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

reweries that you can tour, or perhaps a visit to an art museum and antique shopping

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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