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The HMDA has been passed in order to provide the general public with the information that could help disclose whether o

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

r not mortgage lenders are able to serve the housing loan needs of their communities and neighborhoods. It also aims to

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

Examples of combination products may in

assist public officials to direct public investments to the areas in the private sector where they may be needed. It ha

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

also been issued to make sure that the patterns in lending follow the stipulations of anti-discrimination policies by

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

means of collecting and disclosing the information about the characteristics of borrowers and their applicants.

The ma

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

Combination pro

or lending institutions such as banks and other mortgage lenders are required to report information for the Home Mortga

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

e Disclosure Act each year. Currently the lending institutions, both nondepository and depository, that prove at least

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

$25 million worth of mortgage loans in a year are required to report these information. The number of institutions requ

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

red to report for HMDA have increased dramatically since 2004.

The information reported by the institutions are submit

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

ed to the FFIEC or the Federal Financial Institutions Examination Council, a coalition comprised of thrift and bank reg

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

latory agencies. Data is collected every 1st of March annually.

The following data are collected:

- the loan ID numbe

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

Following aspects would a

r and application date
- the type of application or loan
- the purposes of the applications or the loans

dd to the challenges in developing combination products:

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

- the purpose of pre-approval and origination
- the type of property being loaned or applied for and its location

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

br> - information about the owner and occupancy
- the amount loaned or the amount that has been applied for

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

- the status of lien for the application or the loan.
- the action taken plus the date of the action
- race,

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

ex, gross, and ethnicity of the borrower
- the income profile of the borrower or applicant
- the type of the

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

Professional from academic institutions, pharmaceutical industries, health care indust

ntity buying the loan if it is sold on a secondary market
- the spread of APR if it is higher than 3% on first m

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

ortgages or 5% for refinances
- whether or not the loan is subject to the HOEPA or the Home Ownership Equity Prote

.

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

tion Act

The HMDA is a means of comparing the lending trends conducted by mortgage lenders. These trends are obser

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

Companies that provide selfless information through particip

ed to make sure that lenders are acting without discrimination or anomalies. With HMDA the general public is protected

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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