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Afraid to drink the water? The public at one point was not only afraid to drink water from their faucets, people refused to swim or go into the water to en

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

joy other water recreational activities. The Public outcry was angry and progressive.

The pollution of the rivers and streams was an untenable result of c

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

Examples of combination products may in

emical pollution, oil spills and the inability of water waste treatment plants to insure the integrity of the water system.

The U.S. Census Bureau reported

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

that more than 80 percent of the population of the U.S. lives in a metropolitan area. These citizens live within a 10 mile radius of a polluted river, lake

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

or ocean. Forty-percent of these waters are not safe for drinking, fishing, swimming or boating.

The Federal Government responded with regulations to moni

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

Combination pro

or the discharge of pollution into the water of the United States. The EPA is the agency charged to implement the pollution control programs.

Some of the

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

programs guidelines including setting wastewater standards for the Industry. The Clean Water Act of was passed in 1972. The primary purpose of the CWA is t

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

restore and protect the quality of the nation’s surface waters.

The ultimate goal of the Clean Water Act was to eliminate the discharge of pollutants into

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

navigable waters. The interim goal was to insure that the nation's waters were "fishable and swimable".

The ultimate goal has become less emphasized over ti

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

e. There is still a clear statement that it is unlawful to discharge pollutants into waterways, except as provided by the terms of the Act. The surface wat

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

rs covered by the Act are defined quite broadly, and include rivers, lakes, intermittent streams, and even wetlands.

The Clean Water Act made it unlawful fo

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

Following aspects would a

r any person to discharge any pollutant from a point source into navigable waters. The Clean Water Act funded the states in excess of 50 billion dollars fo

dd to the challenges in developing combination products:

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

the construction of sewage treatment plants under the construction grants program.

The Clean Water Act gave the states the primary responsibility for the

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

implementation and enforcement of the statutes for their local waterways. The act required that all state beneficial uses and their criteria must comply w

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

th the "fishable" and "swimable" goals of the act. The states waterways had to be able to support aquatic life and recreational use.

The original terms of Th

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

Clean Water Act does not address ground water pollution directly. The CWA statutes do however employ regulatory and non regulatory tools that are mandate

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

Professional from academic institutions, pharmaceutical industries, health care indust

the criteria for states that sharply reduce direct pollutant discharges into waterways.

Following the passage of CWA the EPA in 1972 more attention has been

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

given to the physical and biological integrity of our rivers and stream. A global action plan has attempted to address other pollution sources including:

.

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

r>

Polluted runoffs
Urban storm sewer systems
Construction sites

The CWA is an ever evolving to meet the challenges of keeping the water system

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

Companies that provide selfless information through particip

afe and secure. The 1987 amendments to the Clean Water Act required Environmental Protection Agency (EPA) to address storm water runoff from industrial sites

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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