Advice You - Finance

The Bankruptcy Abuse and Consumer Protection Act, signed into law by President Bush last April, promises changes to Federal ban

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

kruptcy law that have been long sought by the lending industry. The bill promises sweeping changes to Federal law, and will 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

ke it much harder for the average consumer in financial trouble to have their debts wiped out by filing for bankruptcy. Recent

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

trends suggest that those considering a bankruptcy filing should do so now, as the line to do so is already getting rather long

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

The bill will make it harder for the average consumer to file under Chapter 7 of the Federal code, which allows the courts to

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

Combination pro

wipe away consumer debt and give the debtor a fresh start. Filings after the October 15 deadline will be subject to a means te

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

t and those that pass a rather generous income gauge will have to file under the more strenuous Chapter 13, which requires a re

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

ayment plan and the assistance of an attorney. Indications are that with the deadline looming, bankruptcy filings are not only

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

higher than they were last year, but they are also higher than anticipated. Nationwide, filings are 20-25% higher than last ye

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

r, and some bankruptcy attorneys say that their business has nearly doubled.

Complicating matters is another law, passed in 20

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

3, that requires credit card companies to establish a payment schedule that allows consumers to repay their debts in a “reasona

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

Following aspects would a

ble” amount of time. Since the beginning of this year, the major credit card companies have doubled their minimum payments fro

dd to the challenges in developing combination products:

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

2% of the balance to 4% of the balance. For the average household with $10,000 in credit card debt, this doubles the minimum

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

onthly payment from $200 to $400, an increase that many consumers cannot afford.

The dramatic increase in bankruptcy filings h

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

s overwhelmed bankruptcy attorneys, who will face the additional burden of being liable for false information filed by their cl

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

ents once the new law takes effect. This additional pending liability, combined with the additional workload, has prompted man

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

Professional from academic institutions, pharmaceutical industries, health care indust

attorneys to raise their fees by an average of nearly 20% over the same time last year.

What does this mean for those with pr

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

blem debt? The deadline for filing under existing law remains October 14, 2005. After that, bankruptcy filings will be more c

.

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

mplicated and expensive. The courts and law offices are already becoming clogged with bankruptcy cases. Anyone who may be con

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

Companies that provide selfless information through particip

idering filing for bankruptcy to overcome his or her problem debt should do so now. Waiting even another day could be too late

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.adviceyou.org.ua/article/91275/adviceyou-Personal-Bankruptcy--If-Its-Unavoidable-File-Now.html">Personal Bankruptcy - If It's Unavoidable, File Now</a>

BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/91275/adviceyou-Personal-Bankruptcy--If-Its-Unavoidable-File-Now.html]Personal Bankruptcy - If It's Unavoidable, File Now[/url]

If you have a large organisation with high transaction volumes, it can be almost impossible to see what your customers really think. But what if your customers could easily contribute to internet mystery shopping and rate your company?

Have you ever thought of starting your own online auction? It is a great opportunity to buy and sell. But it also allows you to own the online traffic. Become an expert in your niche and build an auction specific to your readers wants.

Website planning should address the three ‘Cs’ of concept, content and consumer to give your business presence in cyberspace every chance of success.

Tags

Links

Advice You - Personal Bankruptcy - If It's Unavoidable, File Now

Related Articles: