Advice You - Finance

In order to apply for bankruptcy protection, either under Chapter 7 or Chapter 13, you must attend a mandatory credit counse

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

ling session. You must attend this credit counseling session within the six months preceding your bankruptcy filing.

You m

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

Examples of combination products may in

ust receive this credit counseling from an organization approved by the Department of Justice’s U.S. Trustee Progra

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

m, except in Alabama and North Carolina where court officials (called Bankruptcy Administrators) approve pre-bankruptcy credit couns

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

ling services. The pre-bankruptcy credit counseling session with the approved credit counseling organization will include an evaluat

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

Combination pro

ion of your personal financial situation, a discussion of the alternatives to bankruptcy; and tools to help you make a personal budg

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

et plan.

A typical credit counseling session will last for about one hour. While these sessions are typically provided in a face to

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

face meeting between the debtor and the credit counselor, they can also be conducted by phone or online.

The credit counseling orga

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

nization will typically charge a fee of approximately $50 for the session, although these fees will vary based on where you live, th

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

e types of services you receive, you ability to pay, and how the counseling was delivered. The counseling organization must disclose

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

all fees to you prior to starting the counseling session. If you cannot afford to pay the fee for credit counseling, you must reques

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

Following aspects would a

t a fee waiver from the counseling organization before the counseling session starts. Credit counseling services are required to pro

dd to the challenges in developing combination products:

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

vide the counseling free of charge to debtors who cannot afford to pay the standard counseling fee.

Once your counseling session is

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

completed, you will receive a certificate as proof of the completion of your counseling. Your credit counselor may not charge extra

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

for this certificate, and they must provide you with the certificate within 24 hours of the completion of your counseling.

You must

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

file a certificate of credit counseling completion when you file for bankruptcy protection. Only credit counseling organizations th

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

Professional from academic institutions, pharmaceutical industries, health care indust

at have been approved by the U.S. Trustee Program may issue these certificates. As a fraud prevention measure, these certificates ar

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

sequentially numbered, and produced through a central automated processing system.

The point to remember is this: you must

.

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

have your credit counseling session completed before you file for bankruptcy. If you do not have a certificate proving tha

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

Companies that provide selfless information through particip

t you have completed your credit counseling, your bankruptcy case will be dismissed, and you will not receive relief from your debts

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 - The Dangers of Not Having Credit Counseling Before you File for Bankruptcy

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