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Just Other Articles - Bankruptcy Defined
Bankruptcy is a legally declared inability or impairment of ability of an individual or organization to pa
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
y their creditors. A declared state of bankruptcy can be requested by creditors in an effort to recoup a p
; 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
ortion of what they are owed; however, in the overwhelming majority of cases, the bankruptcy is initiated
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
by the bankrupt individual or organization.
Bankruptcy occurs when a business cannot meet its debt obliga
Bankruptcy occurs when a business cannot meet its debt obliga
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
tions and petitions a federal court either for reorganization of its debts or liquidation of its assets (a
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
though this action has a negative impact on a credit rating).
It also refers to statutes and judicial pro
It also refers to statutes and judicial pro
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
ceedings involving persons or businesses that cannot pay their debts and seek the assistance of the court
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
in getting a fresh start. Under the protection of the bankruptcy court, debtors may be released from or “d
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ischarged” from their debts perhaps by paying a portion of each debt. Bankruptcy judges preside over these
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
proceedings. The person with the debt is called the debtor and the people or companies to whom the debtor
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
owes money are called creditors.
When you are unable to pay your debts, you submit yourself to the protec
When you are unable to pay your debts, you submit yourself to the protec
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
tion of the state. A person or business may voluntarily declare bankruptcy or may be petitioned into bankr
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
uptcy by his creditors. Once in bankruptcy, the person surrenders his assets to a trustee in bankruptcy wh
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
o sells the assets for the benefit of the bankrupt’s creditors, first the secured creditors then the unsec
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
ured creditors. Once a person is discharged from bankruptcy, none of his former creditors may pursue him f
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
r his former debts.
The primary purposes of the laws of bankruptcy are: (1) to give an honest debtor a "f
The primary purposes of the laws of bankruptcy are: (1) to give an honest debtor a "f
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
resh start" in life by relieving the debtor of most debts, and (2) to repay creditors in an orderly manner
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
to the extent that the debtor has the means available for payment.
There are two types of bankruptcy: In
There are two types of bankruptcy: In
.
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
voluntary Bankruptcy, where creditors or lenders file a petition against the debtor (person in debt), and
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
Voluntary Bankruptcy, where the debtor files a petition claiming inability to meet creditors' requirements
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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