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Federal enterprise architecture is a Presidential initiative aimed at making the Federal government capable of handl

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

ing challenges in the new information age. The initiative, headed by the Office of Management and Budget (OMB), prop

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

Examples of combination products may in

ses to change the governmental perspective to one that is citizen-centered, result-oriented, market-based and custom

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

r-focused through a new business-based framework called the Federal Enterprise Architecture (FEA).

The development

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

f this new model dates back to February 2002. The aim was to streamline the processes and combine the work across t

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

Combination pro

he agencies, according to the policies and programs of the Federal government. The Office of Management and Budget

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

OMB) is focused on helping agencies develop their enterprise architecture programs so that they can benefit from usi

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

g EA as a strategic planning tool. OMB is striving to help agencies link departmental-level EA throughout their oper

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

tions, so that its value is reflected in both internal operational decision-making and the identification of governm

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

ent-wide common solutions for improved service to citizens.

The OMB helps agencies develop their own enterprise arc

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

itecture systems. OMB also assists agencies in linking departmental-level enterprise architecture. This aids in crea

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

Following aspects would a

ing a value in internal decision-making, as well as the governmental solutions. Federal enterprise architecture al

dd to the challenges in developing combination products:

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

o provides profiles that help agencies utilize resources, and adopt standards and the best practices.

Another featu

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

re is the CORE.gov, or the Component Organization and Registration Environment, which facilitates inter-agency coope

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

ation, and the development of component-based applications. The information resources of the CORE.gov can be shared

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

r reused by agencies to improve the IT investment portfolio. This resource is a registry that registers the processe

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

Professional from academic institutions, pharmaceutical industries, health care indust

, capabilities, practices or software the inter-agency or intra-agency teams have created, making use of the resourc

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

es of the CORE.gov.

The Federal Enterprise Architecture Management System (FEAMS), an Internet-based enterprise arc

.

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

itecture repository and analysis tool, is used for the maintenance of the Federal enterprise architecture. The FEA

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

Companies that provide selfless information through particip

artners include the Chief Information Officers Council, the Chief Architects Forum and the Industry Advisory Council

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.diggit.org.ua/article/44859/diggit-Federal-Enterprise-Architecture.html">Federal Enterprise Architecture</a>

BB link (for phorums):
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