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Jargon Buster

• Adverse Credit: used to describe a person who has a history of defaulting on credit repayments, ha

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

s county court judgements or has been declared bankrupt.
• APR (Annual Percentage Rate): the total amount of interest

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

Examples of combination products may in

nd other fees charged on a loan.
• Arrears: when a borrower has fallen behind on loan or mortgage repayments.

• <

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

>Bad Credit: Common practices that can damage a credit rating including making late payments, skipping payments, exceeding car

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

limits or declaring bankruptcy.

• Broker: an individual who sources financial products best suited to an individual's

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

Combination pro

needs

• Cashback: an incentive whereby the borrower receives back a sum of money when taking out a loan

• CCJ

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

(County Court Judgement): a court order against a borrower demanding they pay back money owed

• Credit Agreement<

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

b>: a signed agreement between the lender and borrower, outlining terms and conditions relating to the loan

• Credit Refer

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

nce Agency: a company the provides lenders with individual's credit details and history

• Credit Score: an applica

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

t's credit status based on searches carried out by credit reference agencies

• Fixed Interest Rate: an interest rate t

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

e remains the same throughout the loan term

• Over-Repyaments: when payments are higher or more frequent than stipulat

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

Following aspects would a

ed in the credit agreement

• Payment Protection: an insurance plan that will take care of loan repayments on your beha

dd to the challenges in developing combination products:

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

f in the event of illness or redundancy

• Secured Loan: where a borrower's property is used as security to guarantee r

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

payment of the loan

• Self-Certification: where the loans company allows the applicant to state his income without pro

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

iding evidence

• Term: the period of time between the beginning loan date on the legal documents and the date the enti

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

e balance of the loan is due

• Under-Repayments: when payments are lower or less frequent than stipulated in the credi

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

Professional from academic institutions, pharmaceutical industries, health care indust

t agreement, often authorised by lenders if the borrower is struggling to make repayments but is committed to making some contribu

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

ion until the situation improves

• Underwriting: the assessment made by a lender to decide whether to approve a loan a

.

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

plication

• Unsecured Loan: a loan that does not require the borrower to use his home as security

• Variable R

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

Companies that provide selfless information through particip

te Interested: an interest rate that will fluctuate throughout the loan term, either up or down depending on market forces.

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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