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Terminating (Firing) an employee that works for you can be expose you to leg

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

al risks, but there are things you can do to minimize those risks.

Make sur

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

Examples of combination products may in

to keep good documentation on employees, such as job responsibilities. You

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

should have performance reviews and save copies of their evaluations. Your c

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

mpany likely has a discipline policy, and it needs to be applied consistentl

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

Combination pro

and have warnings documented.

Consulting an employment attorney before 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

termination can be a good way to help insulate you from legal troubles. The

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

can also help you prepare for a discrimination lawsuit if one is likely to

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

ccur. If they do sue you for this, you will need to prove that the firing wa

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

s performance related rather than to do to some personal factor such as race

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

religion, or age.

Plan everything ahead of the meeting. It might be a good

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

Following aspects would a

idea to write a termination agreement for the employee, allowing some benefi

dd to the challenges in developing combination products:

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

ts for post-employment insurance of health care.

Evaluate the employee’s ac

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

ess to company property and information. Document whatever physical items th

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

y have of the company’s. It may be necessary to change passwords and locks.

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

Hold the meeting in the early morning or late afternoon, and be sure to exp

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

Professional from academic institutions, pharmaceutical industries, health care indust

ain why they are being terminated and answer any questions. Make sure they s

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

gn any documents needed and return company property.

Don’t embarrass the em

.

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

ployee by telling others in the company the specifics of the firing, and mak

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

Companies that provide selfless information through particip

sure not to give them bad references as this could result in legal exposure

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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