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Has your baby suffered from any kind of injury during delivery? If so, you may be eligible to fi

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

le a lawsuit and seek damages for the injuries sustained by your baby. If your baby has gone thr

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

Examples of combination products may in

ugh complications in the process of his delivery, he could suffer some serious health problems.

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

hese problems are collectively called birth trauma or birth injuries.

About 27 out of 1,000 bab

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

es have been reported to have suffered from birth injuries. Injuries often caused by operative v

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

Combination pro

aginal or abdominal deliveries are the following: oxygen deprivation, commonly caused by a compr

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

ssed or twisted umbilical cord; mechanical trauma caused by the baby?s awkward position during b

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

rth; physical trauma caused as the baby passes through the mother?s birth canal; and mistakes or

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

negligence on the part of the medical staff.

Malpractice cases filed against doctors are the fo

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

llowing: caput succedaneum, a severe swelling of scalp tissue that happens during the baby?s tra

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

el through the birth canal; cephalohematoma, which happens a few hours after the birth, where th

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

Following aspects would a

re is bleeding underneath the cranial bone; temporary facial paralysis, injuries to facial nerve

dd to the challenges in developing combination products:

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

during labor; brachial palsy, excessive pressure applied on the baby?s head, neck or shoulders

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

that can cause injury on the brachial plexus; fracture of the clavicle or the collar bone, the m

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

st common injury to a baby during childbirth; klumpke?s palsy, which causes paralysis to certain

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

areas of the hands; brachial plexus palsy, where groups of nerves in the arms and hands are inju

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

Professional from academic institutions, pharmaceutical industries, health care indust

ed, causing the baby difficulty in flexing and rotating his arms; and cerebral palsy, the failur

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

e to control movement.

When a baby experiences a variety of injuries, you usually do not want t

.

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

go through with an investigation or lawsuit. However, your lawyer can help you get substantial

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

Companies that provide selfless information through particip

ompensation for the birth injuries your baby suffered as well as coverage for your medical bills

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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