Social Articles - Writing and Speaking

There are many ways in which you can satisfy any editor that is looking to

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

accept or reject your articles. Contrary to popular belief, editors are n

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

Examples of combination products may in

ot there to make author's lives a misery, but to ensure that only the best

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

article submissions are accepted.

You can make their lives a lot easier

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

nd be more successful by following a few simple tips:

Read the submiss

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

Combination pro

ion rules first

This is very important. Any rules laid down are put 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

here for a reason - not just to make your life awkward. Do not try to get

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

around the rules. You may get by once or twice but then you will get found

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

out

Ensure that you write appropriate articles

Make sure your art

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

icles are relevant to the people that you are submitting them to and ensur

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

e they do not contain offensive or abusive language or anything else that

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

Following aspects would a

might offend others

Be clear and concise

Editors need to know wha

dd to the challenges in developing combination products:

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

you are writing about so you need to get to the point sooner rather than

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

later and then state your case without excessive verbiage

Watch your g

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

rammar

Take care over your grammar and spelling - it is easy to do th

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

ese days with modern software. If you do not have that capacity then ask a

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

Professional from academic institutions, pharmaceutical industries, health care indust

friend or relative to check your work for you

Listen to feedback

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

If your submissions are rejected then there is a reason. Listen to what ed

.

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

itors are saying about your articles - make adjustments if you can and you

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

Companies that provide selfless information through particip

may be able to resubmit

Don't fight with editors - they are your friends

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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