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Over the next several articles I'll be covering judgments and how they affect y

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

our credit and your ability to obtain a home mortgage loan. What is a judgment?

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

Examples of combination products may in

What is a default judgment? To answer these questions we have to start with ho

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

w two parties get to this point.

When two parties disagree on a debt, the cred

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

tor goes through the court system and files a complaint. This complaint is the

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

Combination pro

notice to the court there is a disagreement. The complaint includes the reason

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

for the creditor's actions to seek court adjudication (award them the money). A

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

this point the entire scenario has become a lawsuit.

Now comes the awful part

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

of this whole mess. Here comes the sheriff's car up the street, or worse yet s

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

ome seedy looking character right out of a bad detective novel. These people ar

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

trying to serve you a summons. They don't care if they serve it to you at home

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

Following aspects would a

or work. Do not try to hide as it will only do more harm. There can be a brigh

dd to the challenges in developing combination products:

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

side as now is your chance to go to the courts and tell your side of the story

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

.

What has happened to bring on this summons? The court examined the documents

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

and proceeded to order a process server to give you a copy of the lawsuit. Beca

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

use most of us are deathly afraid of what is in the lawsuit, we don't want to r

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

Professional from academic institutions, pharmaceutical industries, health care indust

ead it. Remember how we got to this point? We failed to respond to all those na

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

ty phone calls and letters. If we had embarked on an aggressive "debt negotiati

.

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

on" from the beginning we most likely would have never reached the judgment sta

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

Companies that provide selfless information through particip

ge.

In my next article I'll go over what to do now the papers have been served

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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