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"I'm an Advil guy" says one TV commercial, or in a series of unlikely scenarios, one depicts a couple of m

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

en fly-fishing and as soon as a man winces with 'arthritic pain' in his shoulder, his friend, in the middl

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

Examples of combination products may in

e of the wilderness, magically takes a new pack of Aleve from his pocket and offers it to his friend. Simi

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

ar situations are shown where it appears as though everyone walks around with a new box of analgesics in t

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

heir pocket in case they or someone they are with complains of an ache or needs some form of pain relief.

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

Combination pro

The acceptance of these unlikely scenes has a subliminal effect on TV viewers for as some politician once

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

said "tell people something often enough and they will believe anything." It is bad enough we are inundate

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

d with commercials for heavily controlled drugs that we should "ask our doctor about" but analgesics are r

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

adily available without prescription on supermarket and pharmacy shelves and as a result, many teenagers w

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

ho succumb to advertising hype, end up as pain killer drug addicts.

"Don't underestimate the analgesic dr

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

g problem amongst teens – it is escalating fast and has reached frightening proportions," said Judy Cutler

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

Following aspects would a

, a well-known nutritionist in Southern California and developer of 'Naturally Painless,' a Natural Pain R

dd to the challenges in developing combination products:

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

elieving spray.

"As a nutritionist I have often come across damage inadvertently caused to kidney and sto

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

ach function that can be directly assigned to irresponsible overuse of analgesics for the slightest ache o

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

r pain. These heavy commercial campaigns have created a generation of hypochondriacs more commonly known a

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

addicts. Just this morning on NPR radio it was announced that teen use of "Oxycontin" (a strong narcotic

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

Professional from academic institutions, pharmaceutical industries, health care indust

pain reliever) has risen since the last survey was done."

These dire consequences have created deep conce

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

rn among our leaders for the future generation of citizens of our country. Stricter control of both the ad

.

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

ertising and distribution of prescription and over the counter drugs would be of some benefit but a switch

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

Companies that provide selfless information through particip

to natural pain remedies with no side effects or addictive properties would be an even better alternative

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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