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Digg It - Accounting Practise Approach And Theory
In the same way, a set of basic assumptions or concepts, thus serve as guidelines for the accounting discipline. These guidelines influence the manner in which accounti
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
ng information is reported. Consequently, the practical application of accounting is more comprehensible if the underlying theoretical base's of accounting is studied.
; 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
If each undertaking reported its own financial information as it saw fit, the result would be chaos. To bring order into the accounting and reporting processes, over t
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
e years the accounting profession has developed an underlying basis for measuring and disclosing the results of business transactions and events. This consists of a set
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
of assumptions, concepts and procedures that together are known as, Generally Accepted Accounting Practise (GAAP).
The existence of GAAP does not imply that all undert
The existence of GAAP does not imply that all undert
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
akings should measure and report on all financial activities in the same manner. No two undertakings are the same; therefore, it would be impractical to have an inflexi
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
le system of measurement and reporting. The accounting profession developed GAAP as a framework which embraces the fundamental principles of measurement and reporting,
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
but within which a certain amount of diversity is possible.
Accounting principles are entirely different from scientific principles. The latter principles are substant
Accounting principles are entirely different from scientific principles. The latter principles are substant
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
iated by extensive experimentation and observation. For example, detailed research and experimentation has ascertained that the speed of light is 3000 000km per second
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
nd, that every molecule of water is made up of two hydrogen and one oxygen atom.
In contrast to the laws of nature, accounting principles are not discovered; they are f
In contrast to the laws of nature, accounting principles are not discovered; they are f
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ormulated to meet the objectives of financial reporting. In other words, a balance sheet is prepared to reflect the financial position of an enterprise at a particular
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
time. This type of disclosure cannot be proved to be correct or incorrect. It is, however, the generally accepted method of reporting on the financial position of an e
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
terprise.
The approach adopted in respect of the setting of standards is to identify the accounting practices that are desirable and thereby to limit differences in the
The approach adopted in respect of the setting of standards is to identify the accounting practices that are desirable and thereby to limit differences in the
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
variety of accounting practices without introducing rigid uniformity or laying down an inflexible set of rules for all circumstances. The objectives are to produce sta
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
ndards with as general as possible an application, but that eliminates undesirable alternatives. This process may well go further than codifying existing practice. How
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
ver, not all situations can be catered for. It must be recognised, therefore, that it will be necessary to exercise judgement in applying statements of GAAP.
Most comp
Most comp
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
any acts around the globe requires that 'the financial statements of a company shall in conformity with generally accepted accounting practice, fairly present the state
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
of affairs and the profit or loss…..'
The overriding requirement of the Company Act is fair representation. The existence of a standard is an aid to both comparability
The overriding requirement of the Company Act is fair representation. The existence of a standard is an aid to both comparability
.
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
and fair presentation; however, compliance with a standard is no guarantee that fair presentation will be achieved in the accounting financial statements. Even though c
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
ompliance with accounting standards is not necessarily sufficient for fair presentation, the standards are nevertheless highly influential and persuasive in that respect
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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