Advice Pool - Health and Fitness

Communicable diseases are the world’s biggest killers of children and among the top causes of death fo

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

r adults in the developing world. Collectively, they claim more than 15 million lives a year with over

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

Examples of combination products may in

80% of these deaths in developing countries. Reversing communicable disease epidemics is one of the M

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

illennium Development Goals. Results depend on evidence-based disease control programs and broader 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

forts to strengthen the capacity of health systems to assure predictable and sustainable financing and

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

Combination pro

service delivery.

As new communicable diseases such as avian flu and sudden acute respiratory syndrom

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

e (SARS) emerge as significant threats to human life and the global economy, and major killers such as

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

HIV/AIDS, malaria, and tuberculosis continue to spread and become resistant to treatment, strengthenin

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

g health systems’ capacity to detect, monitor, and mitigate the spread of communicable diseases is par

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

mount.

There is growing consensus that insufficient and poorly managed human resources for health cap

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

city is a key constraint. Specific efforts to improve countries’ capacity to achieve communicable dis

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

Following aspects would a

ease outcomes must be integrated with the country’s overall health program and be aligned with efforts

dd to the challenges in developing combination products:

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

in other sectors that influence health, including water and sanitation, education, and agriculture.

W

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

e (World Bank) committed US$334 million to prevent, control, and treat, communicable diseases during f

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

scal year 2006 (July 1, 2000—June 30, 2006).

We moved quickly to help relieve the disruption caused b

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

the Avian Influenza by working with partner agencies to provide technical and financial assistance to

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

Professional from academic institutions, pharmaceutical industries, health care indust

needy countries.

We champion partnerships to fight diseases such as HIV/AIDS, TB, malaria, river bli

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

dness and other tropical diseases and to expand immunization programs.

We are taking a lead on innova

.

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

tive financing mechanisms, supporting the G8 as it explores Advance Market Commitments to accelerate a

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

Companies that provide selfless information through particip

cess to priority new vaccines.

We intensified support for malaria control through the Booster Program

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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This article describes some frequently asked questions regarding cash back credit cards.

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Advice Pool - Communicable Diseases

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