Actual - Real Estate

Many grassroots organizations and elected political officials have worked tirelessly to enact legislat

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

ion to assist Americans in rural and urban areas with access to adequate banking services. In part tho

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

Examples of combination products may in

e efforts have resulted in the creation of the Community Reinvestment Act (CRA). This act has provided

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

many Americans with the opportunity to own their own home. In many instances, without the products and

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

services afforded them through this act, home ownership, would not have been possible.

The Office of

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

Combination pro

hrift Supervision (OTS) threatens to compromise the effectiveness of the Community Reinvestment Act (C

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

RA).

Savings and Loans institutions have been in the forefront of mortgage lending throughout the nat

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

on. In many areas they represent the only viable choice for a consumer.

This could all change with th

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

stroke of a pen, if OTS is allowed to move forward with its planned proposal. The proposal is an atte

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

pt to fragment the compliance process and allow for thrifts with a billion or more in assets to set th

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

ir own criteria for determining what community needs they choose to meet, an option that does not exis

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

Following aspects would a

t currently. Current assessments could necessitate the opening of a branch or branches, placement of a

dd to the challenges in developing combination products:

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

ATM or kiosk, as well as special product offerings, such as low interest loans and no private mortgag

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

insurance.

CRA was designed to ensure that the banking needs of low to moderate income communities i

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

urban and rural areas, were being met. OTS' proposal would undermine and weaken CRA legislation, by a

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

lowing savings and loans to receive CRA credit for assisting upscale communities with banking services

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

Professional from academic institutions, pharmaceutical industries, health care indust

. Thereby effectively creating a loophole within the CRA program, should an institution wish to opt ou

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

of serving the under-served.

January 24, 2007 was the cutoff date for you to register your opinion w

.

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

th OTS. However, the vote is not in and you can contact your representatives in Congress and in the Se

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

Companies that provide selfless information through particip

ate to voice your opinion. Spread the word in the communities that you serve, there's a call to action

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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