Answers - Legal

In medicine, a burn is a type of injury to the skin caused by heat, cold, electricity, chemicals, or radiatio

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

n.

Burns are most commonly caused by exposure to flames, hot objects, hot liquids (scalds), or radiation (e.

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

Examples of combination products may in

. sunburn). Electrical burns are less common, but are potentially more serious, as the depth of the burn is u

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

sually greater than is apparent, and cardiac arrhythmias may occur.

It is estimated that around 112,000 peop

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

e visit Accident and Emergency departments each year as a result of burns or scalds and that at least a furth

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

Combination pro

r 250,000 people visit GP surgeries for burns and scald injuries.

Around 7,800 people each year are admitted

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

to hospital or specialist burns units with burns and scalds. Over 200 people die as a result of these injuri

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

s each year.

Children

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

under 5 years old account for nearly 45% of all severe burns and scalds. About 50% of these accidents ha

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

ppen in the kitchen.

Cups of hot drinks are involved in about 1,265 severe burns a year (requiring admission

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

to hospital), of which 1,100 occur with children less than 5 years of age. Most involve the child reaching up

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

Following aspects would a

and pulling a mug or cup of hot drink on to himself or herself.

Baths are involved in over 570 severe burns

dd to the challenges in developing combination products:

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

a year. Most involve an unsupervised child falling or climbing into a bath of very hot water.

Other common c

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

uses of severe burns include kettles, teapots and coffee-pots, jugs of hot water, saucepans, irons, cookers,

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

ires and heaters, and chip pans and deep fat fryers.

If you or someone you know have been injured as a resul

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

t of a burn injury, consideration should be given as to whether there is a potential ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

tionalinjuryclaims.com/amounts.html" target="_blank">claim for compensation and it may be prud

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

nt to seek advise from a specialist solicitor on a true no win , no fee* basis. There is very likely to be an

.

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

insurer responsible to pay such compensation, whether it be an accident at work [employers liability insuran

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

Companies that provide selfless information through particip

e], at some other person or bodies premises [ public liability insurance] or at home [ household insurance]

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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Answers - Burns - Causes and Claiming Compensation

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