Main Subject - Business

We've all heard tales of office Christmas parties that ran amuck. Coworkers get caught making out in the copy room or a storage closet. Reports of after-hours office frolicking run like wil

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

dfire through the halls and floors of businesses. These shenanigans occur in all types of companies.

Office romance isn't only the tipsy pawing of revelers. Coworkers date. They even marr

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

Examples of combination products may in

.

Does office romance negatively affect office atmosphere and the service provided? I'd like to share a work story, and you can tell me if you think office romance is detrimental.

One time

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

, at band camp...no, not really, but it definitely left me feeling LIKE I was at bamp camp...

For a time, I worked for a satellite office of a large law firm. I was the legal secretary for

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

husband and wife team. Being assigned to two attorneys married to each other was...interesting, to say the least. The entire staff could tell in the first two minutes on Monday mornings ho

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

Combination pro

their weekends went. If it had been a bad weekend, I was offered condolences.

The thermostat which controlled both of their offices was located in husband-attorney's office. My desk was c

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

onveniently across from their doors. One particular "bad weekend" Monday morning, Mrs. Attorney came out to my station and said, "Would you tell HIM to turn up the heat, I'm cold," and retur

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

ed immediately to her office, shutting the door firmly behind her.

I stopped typing, fully aware that our close proximity created the strong likelihood that Mr. Attorney had already heard wh

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

at she said. I was also aware that the secretary behind me had stopped typing as well. The day's antics had begun.

I stood up, smoothed my blouse, and ventured into Mr. Attorney's office.

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

He was typing and didn't immediately acknowledge my presence. Finally, he said, "...yes?" I dutifully delivered the message. Silence reigned. Well, silence reigned in those four walls. I

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

heard shuffling and whispers as staff began clustering near my station.

Mr. Attorney swiveled his chair to face me, peering at me over his glasses. "Do tell, if you will, my lovely wife tha

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

Following aspects would a

t if she had dressed appropriately for the weather, she wouldn't now be complaining that she is cold."

Silence reigned everywhere.

I walked out of his office. Exchanging glances with my co

dd to the challenges in developing combination products:

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

orkers who were poised to scatter but too curious to immediately beat a retreat, I veered right and knocked on Mrs. Attorney's door. I gained entrance, and dutifully delivered the quoted rep

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

ly. Silence reigned again. Coworker shuffling had ceased at that point. All ears were at attention.

Mrs. Attorney said, in a voice an octave higher, "Will you please inform him that my st

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

te of dress is none of his business and that if he ignores a reasonable request it will not bode well this evening."

I returned to Mr. Attorney's doorway, repeating Mrs. Attorney's words. H

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

s response was, "All reasonable requests are considered. It is the unreasonable requests that are denied, in toto."

I updated Mrs. Attorney and announced that I was going back to my

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

Professional from academic institutions, pharmaceutical industries, health care indust

desk, to work (while wondering if emphasis on "work" filtered through).

My fingers typed senseless words on the screen as the thermostat dance began. She walked in his office, flipped the c

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

ntrol and went back into her office. The sound of the heat kicking in muted the return of coworker shuffling. They backed away but remained a rapt audience.

His chair squeaked as he got 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

, turned the heat off, and sat down with more squeaking.

Heels clicked (which was pretty amazing since the floors were carpeted) as she made another control-flipping appearance.

I chose to

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

Companies that provide selfless information through particip

ake my morning break earlier than usual that morning.

Yes, I believe office romance definitely affects office atmosphere. Based on my personal observation, it affects client service as well

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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