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If you are a doctor, you are most likely to face a malpractice suit. There

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

can be situations when your patient is not satisfied with the results. In

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

Examples of combination products may in

hat case, you are likely to face problems. Sometimes doctors get into probl

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

ms when they are not even guilty of the act.

In malpractice suits, the rel

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

tionship with the patients plays a very important role. If the doctor trie

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

Combination pro

to become more attentive for the patient, these kinds of cases can be avoi

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 easily. If a patient develops a grudge against any doctor, he can sue th

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

doctor. So, to avoid such situations, it is better to follow some rules.

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

ay more attention to your patients.

Try to be very friendly and caring.

G

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

ve your patient an overview of how you have planned his treatment.

The fri

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

ndlier and caring you become, the better are the prospects for a doctor.

I

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

Following aspects would a

there could be any situation for any adverse effect while treatment, docto

dd to the challenges in developing combination products:

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

must inform the patient. This can be proved to be very helpful if a patien

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

sues the doctor later on.

Always prepare a detailed medical report for ev

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

ry patient. This report should be given to patients as well. This report sh

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

uld be clear with what has happened with the patient.

In very rare cases o

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

Professional from academic institutions, pharmaceutical industries, health care indust

ly, a doctor withholds the necessary information from the patients. So, as

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

a doctor, always be prepared for a possible lawsuit against you. The best

.

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

ay, as described earlier to avoid such situations is that try to be friendl

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

Companies that provide selfless information through particip

and caring for your patients and be very clear about the medical treatment

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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