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For most parents, the birth of a child is an exciting and joyous experience. But nowadays, 3 to 4

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

percent of newborns suffer from birth-related injuries. In the United States, cerebral palsy has

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

Examples of combination products may in

become a serious birth-related injury which affects 5,000 to 10,000 infants each year.

There are

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

different types of birth-related injuries that may happen before, during, or after the birth of a

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

child. Although there are several types of birth injuries, one of the most popular and common ty

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

Combination pro

e of birth injury is cerebral palsy.

Rather than a disease, cerebral palsy in newborn babies is

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

physical condition that is caused by brain damage before, during, or after birth. There are four

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

different types of cerebral palsy: spastic cerebral palsy, ataxic cerebral palsy, athetoid cereb

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

al palsy, and mixed cerebral palsy. Each type of cerebral palsy has its own characteristics. Of t

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

e four types of cerebral palsy, spastic cerebral palsy is the most common type. It accounts for e

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

ghty percent of all cases today in the United States.

Birth injury-related cerebral palsy is usu

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

Following aspects would a

ally caused by birth asphyxia (lack of oxygen during the birth process), a complex condition whic

dd to the challenges in developing combination products:

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

is difficult to predict or prevent.

Premature birth, low birth weight, hemorrhage in the child'

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

brain, an infection or illness in the mother like rubella, toxoplasmosis; intrauterine exposure

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

to drugs or alcohol are other reasons for birth injury related cerebral palsy.

Even though docto

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

s and nurses are trained to identify symptoms of cerebral palsy, in most cases they fail to recog

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

Professional from academic institutions, pharmaceutical industries, health care indust

ize the problem of brain injury in newborn babies. This failure may lead to birth injury related

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

cerebral palsy. When cerebral palsy is caused due to birth injury (negligence), it becomes a case

.

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

of medical malpractice .The parents of victims can claim for compensation for life long care. Wit

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

Companies that provide selfless information through particip

the help of a cerebral palsy lawyer, victims can easily win compensation for medical malpractice

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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