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I have friends who have spent most of their working lives treading water when it comes to finances. Everytime their income increases (raise, new job, etc.) they add another debt. Everytim

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

e their income decreases they begin racking up credit card debt to make their monthly payments. The latter is so common there is even a term for it; it's called "subsistence living."

Mos

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

Examples of combination products may in

people who tread this financial water are able to dig themselves out if given enough time. But what happens when the income takes too big a hit or debt grows too high (unforseen medical

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

expenses, etc.). That is when you might consider taking advantage of the Bankruptcy Code. Bankruptcy is a process under federal law designed to provide financial relief to the debtor by r

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

solving and settling debts, and provide protection to creditors. There are special courts set up for administering the bankruptcy laws under the Bankruptcy Code. Bankruptcy is not designe

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

Combination pro

to give creditors everything they would have been entitled to had bankruptcy not been filed. Instead, bankruptcy is intended to provide the debtor with a fresh start in his or her financ

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

ial affairs while allowing creditors to recover at least a portion of what is owed.

The Rules Under Liquidation The Bankruptcy Code allows anyone who is a resident, dom

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

ciled, conducting business, or owns property in the United States to file bankruptcy. This applies to those who are U.S. citizens or have a greencard. Recent legislation has severely rest

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

icted the ease with which a debtor may file bankruptcy so you may want to consult a bankruptcy lawyer before filing. The debtor does not have to show that he or she is insolvent (i.e. can

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

't pay the bills) to qualify for bankruptcy, but if the debtor has had a case dismissed for lack of cooperation the debtor is prohibited from filing again for a period of 180 days. This p

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

ovision is designed to prevent debtor's from stringing out creditors by having a case dismissed multiple times.

Automatic Stay Once the debtor files for bankruptcy pro

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

Following aspects would a

ection an "Automatic Stay" goes into effect. This means that all collection actions taken by a creditor must immediately cease. The Automatic Stay applies to all creditors whether they kn

dd to the challenges in developing combination products:

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

ow about the bankruptcy or not.

One common scenario is when a home is foreclosed on and set for auction. I have been at the courthouse steps on more than one occasion to bid on a foreclo

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

ed home when the court clerk received a telephone call from the bankruptcy court instructing that the auction be cancelled due to bankruptcy filing. Many debtors, in fact, wait until the

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

ay and hour of the foreclosure auction before filing bankruptcy realizing the filing will prevent sale of the home. Even at this late hour the Automatic Stay goes into effect.

Or

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

der of Adequate Protection This does not mean that the debtor does not have to pay for the home. To the contrary, the bankruptcy court will draft an order of adequate protection

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

Professional from academic institutions, pharmaceutical industries, health care indust

to protect the creditor. If the debtor wants to keep the home, the order will direct that the debtor bring all arrearages current and continue monthly payments during the course of the ba

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

kruptcy proceedings. If the debtor fails to make the payments as provided in the order the credior can apply for a default and have the Automatic Stay lifted to pursue the foreclosure act

.

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

ion.

Financial Documents If you file for bankruptcy protection you will be required to provide financial and legal forms showing your assets and liabilites. Do not try

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

Companies that provide selfless information through particip

o hide assets. If you are found to have obtained a bankruptcy discharge while hiding assets, the court will reopen the case and severly penalize you for your fraudulent misrepresentations

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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