Advice You - Business

In September 2004, President Bush signed the $146 billion tax cut bill restoring the recently expired busin

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

ess Research & Experimentation Tax Credit. The 18-month renewal of the research and experimentation tax cre

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

Examples of combination products may in

dit, which expired June 30 2004, was the most expensive item with an expected $7.6 billion cost through 201

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

4.

Process Improvement Qualifies

If you are spending money on ISO 9000, six-sigma, lean manufacturing, TQ

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

M, or any other initiative focused on improving your products or processes, then you could qualify. This in

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

Combination pro

cludes software purchases, training courses, labor, and of course the purchase of any Policies, Procedures

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

and Forms products or services.

An Immediate Source of Cash

This is an actual dollar-for-dollar tax credi

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

against your tax liability and not a deduction. You can deduct all costs in the year incurred. And better

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

yet, these regulations are retroactive, which means you can get a refund for previous years.

Requirements

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

to qualify

If you fit these five basic requirements for research, then you might qualify under the latest

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

regulations.

1. New or Improved Product, Process or Software. Research must derive ways to improve a produ

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

Following aspects would a

ct or process such as development or improvement of a formula, invention or technique.

2. Technological. R

dd to the challenges in developing combination products:

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

esearch objective must be to discover technological information, based upon principals including computer s

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

cience or engineering.

3. Research Involves Uncertainty or Risk. It must involve uncertainty or risk assoc

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

ated with the design or method of design achievement, not including general business risk.

4. Experimentat

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

ion Process. It must be well-documented and include failed and successful efforts.

5. Permitted Process. A

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

Professional from academic institutions, pharmaceutical industries, health care indust

ctivity for product or process improvement must relate to a function, performance, reliability or quality.

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

Your Tax Credits are Waiting for You

There is no better time to obtain ISO auditor training, well-defined

.

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

process training, business process consulting, or to get the maximum value out of a helpful key like the M

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

Companies that provide selfless information through particip

anagement Procedures Value Series. Tax credits may expire again later in 2005, so act before it is too late

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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