E-Articles - Health and Fitness

For most, the holiday season brings thoughts of happiness and joy... however for others the holiday season can b

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

ring two very unwelcome guests known as anxiety and depression. These two nasty intruders often bring along feel

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

Examples of combination products may in

ings of overwhelmed pressures as individuals prepare to try to meet all of their social expectations.

We all ex

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

perience the holiday season differently... some will become depressed as they think back over lost time and lost

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

loved ones. People can often feel alone and empty during this season. Sometimes people that battle with anxiety

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

Combination pro

and depression during the holidays become depressed when they think back to missed goals or accomplishments.

T

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

his time of year is the time when we all start looking back at the last twelve months and we try to look ahead t

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

wards the next twelve months. But sometimes we get stuck... just looking back... not looking forward because we

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

can't stop focusing on our failures from the year that has so quickly passed by. Once those thoughts of failure

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

have set in... the partners in crime known as anxiety and depression come out and show their ugly heads again.

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

If you have get stuck looking back and forget to look forward... I want you to stop... grab your rear view mirro

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

Following aspects would a

r (figuratively) and throw it out the window. Stop dwelling on things that you can't change and start looking to

dd to the challenges in developing combination products:

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

wards the things that you can do in the next year ahead.

The holiday season spans about a six week period and d

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

uring that time frame we need to make sure that we give ourselves enough time to get all of our expectations tak

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

n care of... with time to spare for relaxation to help relieve the holiday anxiety and depression symptoms that

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

may have occurred. Don't save all of your shopping till the last minute. The last minute is when you want to be

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

Professional from academic institutions, pharmaceutical industries, health care indust

relaxing, melting those holiday anxieties away.

The holidays can bring you on a roller coaster ride of mixed em

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

otions. We often tend to reminisce and reflect about our past... maybe we are depressed because we can not get h

.

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

ome for the holidays... or maybe we didn't meet our goals last year...

How can we battle this tag team? How do

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

Companies that provide selfless information through particip

we stop anxiety and depression when they tag along for the holiday season? How do we melt away the holiday blues

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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