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Just recently, a friend of mine from the church we both go to, had cataract surgery. He told me that after he was done, he saw better th

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

an he had ever seen since he was a kid. You had to see the look of joy all over his face. Yes, cataract surgery, especially with today's

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

Examples of combination products may in

modern methods, is a great thing. However, there are still risks involved in having this kind of surgery. This article is simply meant

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

o point them out so that you can make an informed decision about whether or not this is something that you want to consider having.

Fir

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

st, let me give you the good news. About 98% of the people who have cataract surgery have wonderful outcomes and vision that is greatly

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

Combination pro

mproved. This is a significant figure and a testament as to how far we have come with this procedure. Still, there is that 2% that we ne

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

ed to be concerned with and what can go wrong in those cases.

One of the most common risks of cataract surgery is Endophthalmitis, whic

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

is an infection inside the eye. To help prevent this from happening, antibiotic eye drops are administered on the day of the surgery. I

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

n most cases, this procedure is all that is needed, but in some cases infection will occur. The statistics for post operative infection

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

re 1 in 3000 surgeries.

A less common risk of cataract surgery is cystoid macular edema. The macula is the central part of the retina.

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

Sometimes, after surgery, this part becomes inflamed, which results in a blurring of vision. A test is then given to determine the exten

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

Following aspects would a

t of the swelling. In some cases, steroids need to be injected into the area itself in order to bring down the swelling, which is always

dd to the challenges in developing combination products:

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

a risk in itself.

Another uncommon risk of cataract surgery is retinal detachment. What happens occasionally during surgery is that flu

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

id seeps through a tear in the retina. When this happens, the retina detaches from the back of the eye. Patients who are nearsighted hav

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

more of a chance of retinal detachment than other patients. This occurs in about one half of one percent of all surgeries.

The most se

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

rious complication from cataract surgery is choroidal hemorrhage. The choroid is a web of blood vessels that supplies that retina with b

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

Professional from academic institutions, pharmaceutical industries, health care indust

ood. Sometimes, during surgery, the choroid will bleed. This is mostly common in patients with high blood pressure and glaucoma. If the

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

bleeding is restricted to a small area, then patients usually recover without much visual loss. However, in the most severe cases, patie

.

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

ts can end up having complete loss of vision.

The most dangerous risks of cataract surgery are fortunately very rare because of today's

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

Companies that provide selfless information through particip

technology. Still, it is important that you are aware of them.

After all, you only get one pair of eyes.

To YOUR Health,

Steve Wagne

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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There was a one hour interview on CNBC with Warren Buffet, the second richest man who has donated $31 billion to charity. Here are some very interesting aspects of his life:

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