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Do you work for a small business or for yourself and want to know if you will be safe and secure when

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

you retire? Small businesses or self-employed individuals can provide benefits so you or the individua

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

Examples of combination products may in

can have peace of mind. They can set up Simplified Employee Pension (SEP) plans. A SEP plan allows an

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

employer to make contributions toward an employees' retirement, and if self-employed, his or her own r

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

tirement.

The SEP rules permit an employer to contribute and deduct each year to each participating e

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

Combination pro

ployee's SEP-IRA up to 15% of the employee's compensation or $30,000, whichever is less. Bonuses and o

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

vertime are included in the employee's compensation. Simplified Employee Pension Plans are funded by e

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

ployer contributions only. A self-employed owner's contribution is based on net profit minus one-half-

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

self-employment tax minus the contribution for him or herself. To determine the contribution and deduc

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

ion amount you must see IRS Publication 560 which is used for Retirement Plans for Small Businesses.

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

hat makes an employee eligible for a SEP? The employee must have worked for the employer for at least

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

Following aspects would a

three of the last five years, they must be at least 21 years of age, and has received from the employe

dd to the challenges in developing combination products:

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

at least $400 in compensation in the tax year. An employer can establish less restrictive participati

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

n requirements for its employees than those listed, but not more restrictive ones. The eligibility rul

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

s must be applied on a persistent basis to all employees including self-employed individuals.

Simplif

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

ed Employee Pensions is one way that small businesses can provide retirement for their employees. Ther

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

Professional from academic institutions, pharmaceutical industries, health care indust

e are several ways that one can plan for the future. Any employer can establish a SEP. The investments

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

are managed by the each individual employee. Simplified Employee Pension plans are very easy to set up

.

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

and will make you feel better knowing that you have something to look forward to when you decide to re

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

Companies that provide selfless information through particip

ire.

You can freely reprint this article as long as the author, bio, and live links are left intact

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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