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One of the most interesting traditions in some offices is that of Secret Santa. The original idea was to allow gift-giving without c

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

ausing the giver to go broke; by giving a present to one person, you symbolically give it to everyone that works there. The basic id

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

Examples of combination products may in

ea is that you pick another employee’s name at random, and then purchase that person a small, inexpensive gift which is then dispers

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

ed at or slightly before Christmas. Although it can be fun, there are some guidelines that should be followed.

Try to stick to a sm

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

ll amount; for even close workers, a few pounds is acceptable. The idea is to show that you like and respect the person; a small gif

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

Combination pro

t is all that is required to demonstrate this. Anything more expensive is actually almost offensive, as it demonstrates too great an

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

affection.

If possible, try to find a gift that the person can use. If they do a lot of yard work, gloves or a trowel are definite

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

ly acceptable. Try to determine what needs they have, and buy the most appropriate gift that you can find that fits within those par

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

meters. As the idea is to buy a small gift, this may not always be possible, but it will definitely be appreciated. It should be not

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

ed that food (especially candy) is also acceptable, as are small pieces of jewelry.

A humorous gift is another possibility. If you

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

can be ironic when you choose the gift, so much the better. A classic is buying a teen-age boy a toy car, but there are other option

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

Following aspects would a

s. You can also apply scatological humor; a number of whoopee cushions and noise-makers are bought at this time of year for Secret S

dd to the challenges in developing combination products:

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

nta gifts. Do try to keep it tasteful, however.

Try at all costs to avoid gifts that are rude, intimate, or just tasteless. As the

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

gift will be given in public, gifts that would be better given in private should be avoided. If you feel the gift must be given, the

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

n give it in private as a special, personal gift. However, gifts that require intimate knowledge or imply some relationship that doe

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

sn’t exist, or are on the limits of taste should definitely be avoided. In essence, the rule that the gift should be acceptable to t

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

Professional from academic institutions, pharmaceutical industries, health care indust

e person receiving the gift should definitely be followed.

It should be noted that these are just guidelines; there are some times

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

when they won’t apply. For example, between really good friends, the price spent on the gift may be increased. However, the guidelin

.

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

es should be followed in general, so as not to cause bad feelings; the idea is to have fun, not hurt people. Secret Santa can be a f

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

Companies that provide selfless information through particip

un tradition, especially among those who are clever and are willing to give what is needed. And it definitely one that builds morale

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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