Advice You - Finance

Sometimes things just don't turn out in business as you would wish them to. We

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

don't plan to fail but sometimes it happens. Bankruptcy is a last resort - bu

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

Examples of combination products may in

t you may need to consider it.

Bankruptcy is a very serious ordeal, not somet

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

ing to be thought about lightly. If you are considering filing for bankruptcy,

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

there are a few things you should evaluate first, before you do.

The first t

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

Combination pro

ing to consider is your eligibility for Chapter 7 protection. If eligible, it

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

will take a majority of your debt away. The guidelines can be strict, but if y

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

u are sincerely in need of such protection, this isn’t out of reach.

Secondly

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

, you need to rethink your alternatives. Filing for bankruptcy can harm your c

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

edit drastically- make sure there is no other way out. You can try debt consol

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

idation, or talking to your creditors yourself. If it doesn’t seem like things

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

Following aspects would a

are working, then it’s time to consider your losses.

What kinds of debts can

dd to the challenges in developing combination products:

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

you relieve yourself of? Child support payments or student loans aren’t eligib

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

le for bankruptcy. Bankruptcy is more for credit, which is often the problem i

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

itself.

If you still think bankruptcy is the only option, make sure you get

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

an experienced attorney to help you through the ordeal. More bills, but an att

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

Professional from academic institutions, pharmaceutical industries, health care indust

rney will make sure the process is conducted correctly. Often, there are stric

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

t guidelines and restrictions you should be aware of. Bankruptcy isn’t somethi

.

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

g you should go through alone.

Whatever the outcome, there is always a place

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

Companies that provide selfless information through particip

to turn to for help - online, on the telephone or in the main street. Use them

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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Advice You - Is Bankruptcy Right For You?

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