Advice You - Business

Journal

1. Is the book of prime entry.

2. As soon as transaction orig

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

inates it is recorded in journal

3. Transactions are recorded in order of occurrence i.

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

. strictly in order of dates.

4. Narration (brief description) is written for each entr

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

y.

5. Ledger folio is written

6. Relevant information cannot be ascertained readily e.

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

. cash in hand can't be found out easily.

7. Final accounts can't be prepared directly

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

Combination pro

from journal.

8. Accuracy of the books can't be tested.

9. Debit and credit amounts of

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

a transaction are recorded in adjacent columns.

10. Journal has two columns one for deb

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

it amount another for credit amount.

11. Journal is not balanced.

12. With the compute

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

ization of accounting journal may not be used for routine transactions like receipts, pu

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

rchases, sales etc

Ledger

1. Is the book of final

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

ntry.

2. Transactions are posted in the ledger after the same have been recorded in the

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

Following aspects would a

journal.

3. Transactions are classified according to the nature and are grouped in the

dd to the challenges in developing combination products:

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

concerned accounts.

4. Narration is not required.

5. Folio of the journal or sub-journ

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

l is written.

6. Since transactions of particular nature are grouped at one place there

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

fore relevant information can be ascertained.

7. Ledger is the basis of preparing final

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

accounts.

8. Accuracy of the books is tested by means of list of balances.

9. Debit an

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

Professional from academic institutions, pharmaceutical industries, health care indust

d credit amounts of a transaction are recorded in two different sides of two different a

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

counts.

10. Ledger has two sides: left side is debit side right side is credit side.

1

.

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

1. Every account in the ledger is balanced at appropriate time.

12. Ledger cannot be av

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

Companies that provide selfless information through particip

ided. However it may be loose leaf ledger or a computerized ledger. But ledger is a must

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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