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Main Subject - Bankruptcy FAQs
As far back as colonial times, every citizen has a constitutional right to file for bank
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
ruptcy. By declaring bankruptcy, one is relieved of mandatory collection activities for
; 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
ebts existing at the time of filing by a legal "stay" on these activities. The first ver
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ion of US bankruptcy or Federal Insolvency laws appeared in 1800, and has been evolving
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ver since.
Chapter 7 or "straight liquidation" bankruptcy permits the retention of exem
Chapter 7 or "straight liquidation" bankruptcy permits the retention of exem
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
t assets and property and can be used by individuals, partnership businesses and corpora
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
ions. Under Chapter 7, recent tax obligations, debts to government units and alimony/chi
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
d support are not exempt. In case of debts incurred during a marriage, both spouses must
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
file for bankruptcy – otherwise the debts are transferred to the non-filing spouse.
Cha
Cha
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
ter 13, or "wage earner reorganization" bankruptcy can only be filed by individuals who
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ave a steady source of income. It can be filed by debtors with unsecured debts that do n
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
ot exceed $100,000 and secured debts that do not exceed $350,000. Basically, filing for
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
hapter 13 bankruptcy indicates an intention and willingness to make good one’s debts wit
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
in five years. With this understanding, the applicant’s existing assets are not liquidat
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
d.
Chapter 11 is a more flexible version of Chapter 13 available to individuals and bus
Chapter 11 is a more flexible version of Chapter 13 available to individuals and bus
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
nesses. It is generally not preferred by individuals, because it entails greater court-r
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
lated expenses and calls for frequent personal appearances in court.
Once Chapter 7 ban
Once Chapter 7 ban
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ruptcy has been legally sanctioned, creditors have no claim on future income. If assets
.
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
have been concealed, misrepresented or surreptitiously transferred at the time of filing
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
for bankruptcy, the discharge from debts can be either refused or declared null and void
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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