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Organisations and individuals supplying or offering to supply second

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

hand electrical equipment should be aware of the important legal obli

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

Examples of combination products may in

ations imposed on them under electricity safety legislation; as follo

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

s:

A person supplying or offering to supply second hand electrical e

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

quipment must have a label attached to the equipment stating that the

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

Combination pro

equipment is second hand.

A business – including major charitable or

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

anisations – supplying or offering to supply second hand electrical e

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

quipment must also attach a label stating that the equipment is secon

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

hand and that the equipment has been inspected and tested and that i

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

complies with Australian/New Zealand Standard(AS/NZS) 3760 - In-serv

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

ce safety inspection and testing of electrical equipment and AS/NZ 57

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

Following aspects would a

61: 2005 - In-service safety inspection and testing of electrical equ

dd to the challenges in developing combination products:

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

pment - second hand electrical equipment prior to sale.

If the item

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

oes not comply with the testing criteria, the business supplying or o

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

ffering to supply second hand electrical equipment must include a cle

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

r statement on the label, stating the equipment is second hand, with

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

Professional from academic institutions, pharmaceutical industries, health care indust

dditional words as follows: WARNING DO NOT USE UNTIL REPAIRED. If the

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

organisation still wishes to sell the item in its defective state th

.

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

provisions of AS/NZ 4701 - requirements for domestic electrical appl

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

Companies that provide selfless information through particip

ances and equipment for reconditioning or parts recycling, shall appl

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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