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Sunglass side shields protect your eyes from glare and bright light, and they're a terrific fashion accessory. But they also

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

offer eye protection, shielding the eye from potentially damaging ultraviolet (UV) light. Experts say that even just short pe

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

Examples of combination products may in

riods of exposure to UV radiation can cause eye damage over a long period of time, just from going out every day without eye

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

protection.

The most common UV damage that eye doctors see are melanomas on the eye lids, acute eye pain, cataracts, and deg

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

enerative changes to the eye. In fact, studies have found that people who don't wear sunglasses, exposing their eyes to UV li

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

Combination pro

ght for hours every day, are three times at risk of developing cataracts. Fortunately, wearing a hat with a brim or sunglasse

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

s when going out on sunny days can do a lot to help protect the eyes from UV radiation.

For those who want to protect their

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

eyes even further, there are sunglasses that come with side shields, which block UV light. You've undoubtedly seen these shie

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

lds on the heavy dark glasses worn by older people who already have cataracts and people who have just come from an eye appoi

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

ntment. But sunglass side shields available for anyone who wants to wear them, either as part of some sunglasses design or as

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

add-ons that can be attached to your existing sunglasses.

For people who wear sunglasses while playing sports or engaging i

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

Following aspects would a

n other outdoor activities, side shields offer an additional level of protection from sand, debris and other material that co

dd to the challenges in developing combination products:

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

uld get into the eye, and many shields have vents so that the lenses of the sunglasses don;'t fog up.

When buying a pair of

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

sunglass side shields, you get what you pay for. Or, rather, you get what you don't pay for – inexpensive sunglasses are usua

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

lly not made with optical-quality glass like prescription glasses, and can cause sight problems down the road from peering 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

rough cheap glass or plastic lenses. And you should look at what the lenses are made from – for complete UV protection, the l

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

Professional from academic institutions, pharmaceutical industries, health care indust

enses should be crafted from polycarbonate or from plastic with a dye that absorbs UV radiation.

Polycarbonate plastic absor

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

bs all UV radiation, while prescription-quality glass or plastic lenses absorb approximately 85 percent of UV radiation. But

.

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

even with lenses that absorb 100 percent of UV radiation, light still can get to the eye from the tops or sides of the sungla

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

Companies that provide selfless information through particip

sses, which is why side shields are an excellent idea for anyone, no matter what your age or how often you go out in the sun.

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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