Subjects - Business

Laser pointers are useful when used at a business meeting to point out areas of inter

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

est on a chart or graph, and very amusing when the kitty chases them around the floor

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

Examples of combination products may in

. But, innocuous as they seem, even the weakest of laser pointers can do damage if th

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

eye is exposed to them directly for a length of time.

Visual disturbances and someti

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

mes damage of the retina or cornea can develop from exposure to a laser pointer. Thou

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

Combination pro

h it may seem silly, eye protection may be necessary to avoid injuries that arise fro

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

m exposure to laser pointers. There is nothing funny about loss of vision caused by ‘

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

laying’ with a laser pointer, so handle them carefully and use them only as intended.

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

Proper eyewear can filter the laser wavelengths and protect the eye. Many places of

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

work have banned laser pointers as being a hazard already, especially with children.

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

Most authorities recommend that children not be allowed to play with laser pointers,

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

Following aspects would a

as the risks far outweigh the fun. Many schools do not allow them to be used for this

dd to the challenges in developing combination products:

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

reason.

The message is one of safety. Protect your eyes and never look directly at th

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

e light from a laser pointer. Also be aware of the direction it is being pointed. N

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

ver point it toward other people. Point it only at the graph or chart. If it is not

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

needed at a particular point, point it at the ceiling or, better yet, turn it off. Th

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

Professional from academic institutions, pharmaceutical industries, health care indust

re are relatively low incidences of adults sustaining permanent injuries from laser p

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

ointers, but it is a possibility, especially when using the more high-powered lasers.

.

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

So be careful and if necessary, use protection. Follow all the safety precautions li

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

Companies that provide selfless information through particip

sted in the instructions that accompanied the laser pointer. Your eyes will thank you

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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Subjects - Laser Pointer Eye Injuries and Laser Safety Eye Protection

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