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The FSA is an independently operating non government organization which has been awarded statutory powers by the Financia

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

l Services and Markets Act (FSMA, 2000). Set up by the government, FSA keeps a close watch on financial services and endeavors to protect

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

Examples of combination products may in

the borrower’s rights. The FSA does so by providing factual and impartial information about the various financial products and services on

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

offer to ensure that the deal is better understood by you so you know that you’re making an informed financial choice.

What Does

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

The FSA Do? The FSMA has given the FSA four statutory objectives which are:

• Market Confidence: The FSA must help maintain the

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

Combination pro

confidence of the borrowers in the prevailing financial system.
• Public Awareness: It is the FSA’s duty to promote public awarenes

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

s and understanding of the financial system to ensure that borrowers don’t get swindled by fraudulent lenders.
• Consumer Protection

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 is the FSA’s responsibility to secure the appropriate protection for consumers who have been cheated or those who have approached the

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

FSA to seek protection against fraudulent lenders or agencies.
• Reduction of Financial Crime: The FSA, through it constant endeavor

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

s must try and reduce instances of financial crime.

FSA regulates most of the financial services in UK such as banks, financial advisors,

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

mortgage remortgage brokers, stock brokers, insurance companies etc. This doesn’t mean that FSA deals with loans, credit cards and insura

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

Following aspects would a

nce schemes directly. It simply regulates these services which are provided by various organizations.

How Do You Lodge A Complain

dd to the challenges in developing combination products:

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

t? There are times when you would have been dissatisfied with the services of your mortgage remortgage broker or even the financi

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

al agency you dealt with. In such circumstances FSA can serve you well and any firm regulated by the FSA will provide you free service to

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

eal with all your doubts. They will assist you in putting forth your complaint to an independent complaints scheme or even take your case

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

to court if necessary.

Follow this checklist and find out if you need to file a complaint:

• You’ve been charged excessively without you

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

Professional from academic institutions, pharmaceutical industries, health care indust

r knowledge
• You were misled and given fraudulent information about a product
• The service didn’t draw your attention toward

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

s some strict condition in the contract
• You were not given any notice about changes to the contract
• You have suffered a los

.

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

s of money because of the agencies irresponsibility

If you answered YES to all the above questions, you need to complain as soon as possi

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

Companies that provide selfless information through particip

ble! The FSA is here to restore your financial faith and make you believe that you have a helping hand to deal with your financial worries

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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