Answers - Legal

You should know what is “informed consent”. Informed consent is to be obtained from

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

well informed patients about their own health care in making decisions on their ow

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

Examples of combination products may in

n free will before the patient is subjected to serious treatment or operation. This

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

is a legal obligation and it is the ethical right of the patient.

The patient sho

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

uld be aware of his rights and participate in the discussions and decisions. And he

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

Combination pro

should be given the freedom to decide on:
1. the alternatives to the proposed

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

operation or treatment.
2. the process and its nature
3. the risks involv

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

ed
4. the extend of the uncertainties involved

And if needed repeat the expla

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

ining part in a simple layman’s language and make sure he understood and accepted 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

he proposed course of treatment/operation.

The informed consent should be legally

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

alid and the patient should be in a competent state of mind and his consent must be

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

Following aspects would a

voluntary. In certain cases the patients feel helpless and vulnerable to any coerc

dd to the challenges in developing combination products:

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

ive tactics. And he or she should be made comfortable and relaxed before the consen

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

t form is signed.

The informed consent process should be a clear acceptance of the

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

proposed treatment or surgery and on his/her own free will. To improve the confide

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

ce of the patient, he should be allowed to seek a second opinion. This action will

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

Professional from academic institutions, pharmaceutical industries, health care indust

make sure the informed consent is a very well informed comprehensive consent.

In s

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

ome delicate cases, the Doctor may be constrained to withhold certain portion of 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

e information. This is physician’s discretion in the best interest of the patient.

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

Companies that provide selfless information through particip

This is also tailored information supplied to obtain the patient’s informed consent

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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