Advice Pool - Legal

If you are hurt or harmed, you are injured. The term injury means damage caused t

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

o the structure or function of the body. It may have been caused by accident or i

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

Examples of combination products may in

flicted deliberately by an external agent. Or it could have been caused by physic

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

l or chemical agent or force. The result may be injured feelings or reputation. I

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

need not be injury to the body. Injury can be categorized as hamstring injury, c

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

Combination pro

ld injury, needle stick, trauma etc.

Hamstring - Tendons at the back of the knee

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

or the side walls of the hollow behind the knee. Pulled hamstring happens to any

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

one in sports.

Cold injury - It happens to those, mostly young and elderly, with

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

and without freezing of body tissues.

Needle-stick injury - A needle or any othe

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

sharp object can cause a stab wound that will lead to exposure to blood or other

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

body fluids. Before anything happens, wash needle-sticks with soap and water.

Tr

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

Following aspects would a

auma - It is a serious bodily injury, wound or shock. Physically or emotionally i

dd to the challenges in developing combination products:

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

flicted injury is also called Trauma.

People with severe injuries are brought to

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

hospitals. Excess heat or cold frostbite will cause injuries or burns. Injuries t

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

the bones are fractures. Cuts and grazes are injuries to the skin. Laceration or

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

bleeding is the result normally. A bruise is a hemorrhage under the skin caused b

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

Professional from academic institutions, pharmaceutical industries, health care indust

y contusion.

Emotional injury can be explained in detail. Damage to one’s self r

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

spect or social standing is an emotional injury. Sexual harassment can cause deep

.

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

emotional injury. Athletic or sports injuries happen in every sporting event.

Th

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

Companies that provide selfless information through particip

re is an element of risk of death in cases of serious bodily injury to the victim

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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