Answers - Real Estate

The first step toward obtaining financing for a home purchase is to select a reputable, quality lender. The next step in the process is for you to ob

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

tain a “pre-approval letter” from that lender. Before I get to that, it is important to note that there is a significant difference between “pre-qual

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

Examples of combination products may in

fication” and “pre-approval.” Most buyers don't understand that there is a difference, but the difference is dramatic and not realizing this could hav

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

a significant impact on the outcome of your home buying efforts. Here is a brief explanation of the two processes:

• “Pre-qualification” does not g

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

arantee you a loan. It merely establishes how much you are capable of paying for a house, based upon what you tell a lender. Most lenders will provid

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

Combination pro

a pre-qualification letter to almost literally anyone that calls them. Accordingly, sellers and listing agents view “pre-qualification” letters with

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

a healthy degree of skepticism. As one very experienced agent stated it succinctly, “pre-qualification letters are not worth the paper they’re printe

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

d on”

• “Pre-approval,” on the other hand, is a much more exhaustive process in which a lender will inspect your credit and financial situation in de

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

ail. This process guarantees you a specific loan amount. It also determines the types of loans for which you may qualify, your interest rate, your mon

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

hly payment amount, etc.

Why you need to obtain a pre-approval letter:

• Because you need to understand your price range BEFORE you begin looking at

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

houses. Simply put, you do NOT want to look at $400,000 homes if your upper price point is $350,000. Why? Because it is difficult to be content wit

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

Following aspects would a

a lower priced home if you’ve gotten used to homes beyond your financial reach

• Because lenders can detect potential problems that might make obtai

dd to the challenges in developing combination products:

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

ing a loan difficult. Credit report errors, high debt balances and an insufficient down payment may be corrected if discovered in a timely fashion. If

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

credit problems are significant enough to keep you from obtaining conventional financing, it’s better to learn about it before you invest time in this

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

emotional and often time-consuming process

• Because you will need to provide the pre-approval letter along with any offer that you submit on any pr

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

perty, so you need to have the letter in hand at the onset of the home search process. The pre-approval letter is viewed as an integral part of any o

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

Professional from academic institutions, pharmaceutical industries, health care indust

fer, and sellers and listing agents expect you to provide this. The absence of such a letter will be perceived quite negatively, and imply a lack of

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

reparedness on your part

In conclusion, you should obtain a pre-approval letter before you start your home buying process. It’s typically a fast and

.

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

easy process, and the reasons for doing this are significant: pre-approval lets you know what you can afford before you become emotionally attached to

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

Companies that provide selfless information through particip

something you can’t, it helps identify and correct loan problems up front before the crisis hits, and it strengthens your ultimate bargaining position

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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