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As an attorney who practices employment law in both Massachusetts and the Federal system, it strikes

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

me as odd, how few rights employees realize they actually have in the work place. Even more suppressi

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

Examples of combination products may in

g is the rights that terminated employees have which they are not aware. I make it a point to discuss

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

with every potential client some basic rights and steps they should take, whether they retain my serv

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

ces or not, whether I take their case or not. Employees who were either terminated or simply quit sho

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

Combination pro

uld understand that they have a right to know everything their employers have said and written about

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

hem during their employment and even their application process.In Massachusetts, every employee has 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

e right under Massachusetts General Laws, chapter 149, section 52C to receive a complete copy of the

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

mployee’s personal file. This file may contain information from their job application, every annual r

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

eview, and any complaints against that employee.

Why is this so important? If you were terminated, o

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

left as a result of conduct the employer took, you will want to seek unemployment benefits. Many tim

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

Following aspects would a

s you are denied those benefits based on something the employer said to the government. You are also

dd to the challenges in developing combination products:

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

ranted an automatic hearing if you are denied. In that hearing, you can question the veracity of thos

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

e comments the employer made, if their were no documents in your personal file to cooperate the story

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

This is a form of discovery that you do not need a lawyer to request.

The state of Massachusetts ta

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

es this rule so seriously that if the employer does not send you your personnel file with in 5 days o

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

Professional from academic institutions, pharmaceutical industries, health care indust

receipt of your request, may result in a criminal prosecutions a fine of $500 - $2,500 dollars. More

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

over, if an employer fails to comply with the request, they are going to face the attorney general,

.

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

here the employee will not be footing the bill.

The above is just one such circumstance where there

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

Companies that provide selfless information through particip

re critical rights that many employees and terminated employees, should but just don’t know they have

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 section talks about the importance of having a mentor in your life. Mentors are individuals who you look up. You may or may not know them personally, but they inspire you to move towards a certain direction.

In the age of the modern workplace, there is an alternative to bulky, paper-bound training manuals. With many offices implementing shared drives with companywide access, a computerized version of your training manual may be just what you need for your office.

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