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Have you ever been asked to write a letter of reference for a co-worker, employee or former employee? Generally, a letter of reference is

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

used to help obtain employment, apply for higher education, or as a character reference for those seeking a government position. This is

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

Examples of combination products may in

n important request, as a well-written letter can be the reason the candidate receives the offer he or she is hoping for.

In all likeliho

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

od, you won’t be asked to write a letter of reference for someone you don’t know or get along with very well. But, if you have any doubts

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

bout writing a recommendation for this person, you should decline the offer and suggest they ask another person. Only write a letter for

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

Combination pro

someone whom you would truly recommend.

A letter of reference doesn’t need to be long and wordy. In the first few sentences, explain how

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

ou know this person (co-worker, neighbor, business acquaintance) and for how long. Mention any shared any experiences such as coaching th

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

e same basketball team, singing in the church choir or working on a project together at the office.

Think of two or three major character

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

traits to describe this person that would be pertinent to the reason you are writing the reference. Are they honest and dependable? Do t

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

hey always finish what they start? While Mike may be the best guitar player you know and can recite lyrics from songs written twenty years

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

ago, chances are these are not reasons he’ll get that job offer. Think of what you would say if you were asked to make a toast to this pe

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

Following aspects would a

son during a special occasion.

A short anecdote describing how this person handled a difficult situation will make your letter stand out

dd to the challenges in developing combination products:

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

from the rest. Think of an incident that made you see this person in a new light. Finally, add a short statement that draws the letter to

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

close.

Here’s a sample letter of reference.

To Whom It May Concern:

I am pleased to write this Letter of Reference for Mike Smith. I

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

have lived next door to Mike for ten years, and we both have served on the XYZ Neighborhood Watch Committee for the past three years.

Mik

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

is a pleasure to work with on this committee. His drive and determination to make our neighborhood a safer place was the catalyst in get

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

Professional from academic institutions, pharmaceutical industries, health care indust

ting our local government to install a traffic light at a busy intersection in our community. Once, during a power outage in rush hour, an

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

risking life and limb, Mike took the initiative to direct traffic himself rather than risk an accident at this intersection.

Mike’s pers

.

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

everance and genuine concern for his fellow citizen are perfect examples of why it is my privilege to recommend him for a position with yo

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

Companies that provide selfless information through particip

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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