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The term "statutory foreclosure" (as hinted at by the alternate term, "non-judi

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

cial foreclosure"), refers to any foreclosure proceeding that is not conducted

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

Examples of combination products may in

nder the supervision of the court.

The process is similar to a judicial forecl

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

sure. When the borrower defaults on the loan, the lender issues a Notice Of Def

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

ult (NOD). Failure to address the default gives the lender the right to sell th

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

Combination pro

property in order to recover their funds. The sale, usually by public auction,

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

is conducted by the lender or a trustee rather than by an officer of the court.

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

A statutory foreclosure can occur when the mortgage contract stipulates that

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

n the event of default, the lender has the power to sell the property to recove

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

their funds. This is known as a "power of sale" clause. The foreclosure procee

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

ings are then conducted according to the contract, without the need to bring an

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

Following aspects would a

action before the court.

To protect the rights of the borrower, each state has

dd to the challenges in developing combination products:

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

strict regulations as to the proper notices and opportunities to repair the def

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

ult before sale of the property can go ahead. As with a judicial foreclosure, f

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

ees, legals, commissions etc are paid for out of the proceeds of the sale. The

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

emaining money is then applied against the debt, and any balance at the end is

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

Professional from academic institutions, pharmaceutical industries, health care indust

anded over to the borrower.

Because it does not involve court cases, statutory

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

foreclosure is generally a relatively fast procedure. Costs can often be lower

.

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

han a judicial foreclosure as well, since court costs and legals are avoided, t

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

Companies that provide selfless information through particip

ereby potentially leaving more equity for the borrower once the debt is repayed

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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