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Main Subject - Personal Bankruptcy
As mentioned earlier, personal bankruptcy can be filed for under Chapter 7(for almost complete elim
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
ination of debts) and the more conditional and restrictive Chapter 13 of the federal bankruptcy cod
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
e. Basically, the provisions under personal bankruptcy allow a genuinely insolvent individual to wi
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
pe the slate clean and make a fresh beginning. If the case is bona fide and the proper procedure is
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
followed, the debtor is guaranteed freedom from financial and mental harassment and by creditors.
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
People file for personal bankruptcy for various reasons. The most common ones are debt incurred by
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
credit card misuse, divorce proceedings and eventual alimony/child support expenses, sudden illnes
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
entailing major medical expenses, accidents, etc.
Though it may often seem like the only feasible
Though it may often seem like the only feasible
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
option, filing for bankruptcy should not be done without weighing all the pros and cons. No indivi
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
dual should consider filing for bankruptcy unless he/she has consulted with an attorney knowledgeab
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
le in US bankruptcy laws. Once filing has been decided on, all necessary forms and other documentat
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ion should be filled in consultation with an attorney.
Updated bankruptcy laws now require a perso
Updated bankruptcy laws now require a perso
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
n filing for Chapter 7 or Chapter 13 bankruptcy to undergo a credit counseling course within six mo
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
nths of actual filing. Counseling will be undertaken by officially appointed professionals. Undergo
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ng credit counseling is compulsory and can be foregone only in cases specially exempted by the cour
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
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
t.
Whether an individual should file for Chapter 7 or Chapter 13 bankruptcy is largely decided by
Whether an individual should file for Chapter 7 or Chapter 13 bankruptcy is largely decided by
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
two factors - the person’s income as compared to the average income for his/her state of residence,
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
and the ratio of his/her debts against available income. Following the October 14, 2005 amendments
.
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
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
, debts towards government units, fines and penalties under federal election law, tax debts, debts
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
towards certain student loans and some others, are not eliminated by filing for personal bankruptcy
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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