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Over the past few years, the use of extranets and intranets by law firms to share critical documents with co-w

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

orkers, clients and co-counsel has been firmly established.

One area in which an extranet is particularly use

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

Examples of combination products may in

ul is in litigation, where a large number of parties require a massive number of documents over a fixed period

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

of time.

Keeping things organized
An extranet provides a single location dedicated to the individual ca

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

e. Access to documents can be defined by the need of the user. For example, documents relating to clients are

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

Combination pro

very different than those required by co-counsel. An extranet allows everything to reside in one place, but a

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

cess can be defined by individual needs. It also automates alerts – so that users know the instant a new docum

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

ent has been posted, and can find it quickly in a dedicated folder.

Many extranets go beyond the simple shari

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

g of documents. Many include tools such as a comment function, calendars, project trackers, and approval funct

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

ions. These tools can be used to report on the all activities and on the progress of the case.

Providing a pe

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

manent record
All actions taken within the extranet are recorded, and most extranets provide powerful sea

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

Following aspects would a

ch tools that allow users to quickly see who did what, and when they did it. All actions are name and date sta

dd to the challenges in developing combination products:

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

mped, providing a complete record of activity in what is often a fast moving environment where documentation i

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

difficult to manage.

Easy to setup and use
Extranets that are offered by application service providers

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

can be created and used in a matter of days. It’s a simple matter of subscribing to a service that provides al

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 technology and training. Many are so intuitive that they require no training at all – they’re as easy to

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

Professional from academic institutions, pharmaceutical industries, health care indust

use as email.

A secure environment
Managing legal documents requires the highest level of security. Ext

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

anets require an id and password for access, and many provide encryption of all transmissions.

And when the c

.

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

ase is over . . .
It is fast and easy to close the extranet and download all of the information. Often,

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

Companies that provide selfless information through particip

itigators will create an extranet for each case they handle, and simply close it at the conclusion of the case

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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