Advice You - Business

Having just come back from what was otherwise a delightful trip abroad, I started stewing abou

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

t the lousy return flight I took.

Why was this experience the absolute worst part of the trip

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

Examples of combination products may in

surpassing the bad plumbing and other inconveniences that I suffered?

That flight is emblema

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

tic of the five reasons flying sucks:

(1) Flying wastes time. Having to check in hours before

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

a flight is unnecessary. When you calculate this lost time, along with what it takes to drive

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

Combination pro

to an airport, park the car, and catch a shuttle, it makes driving to your destination, if it

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

s within 300-400 miles, seem more convenient.

(2) The airline made me wait 5 hours between co

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

nnecting flights, although TWO earlier flights were available. Undoubtedly, they did this beca

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

se I was traveling on a discounted fare, and they could market the more convenient flights at

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

higher fares.

(3) The flight crew embodied the worst in service workers. They were authoritar

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

an and not subject to supervision and oversight. They insisted on invoking “rules” that they m

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

Following aspects would a

de up on the spot regarding the use of overhead compartments.

(4) Every bathroom on the plane

dd to the challenges in developing combination products:

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

malfunctioned, yet the crew did not apologize once for the inconvenience to passengers.

(5)

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

aving drifted off to sleep, my shoulder must have intruded a few inches into the service aisle

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

before I heard a rude warning, “Look out!” which was immediately followed by a pounding taken

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

from one of the wide hips of the flight attendant.

When airlines believe that they can not on

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

Professional from academic institutions, pharmaceutical industries, health care indust

ly inconvenience you, waste your time, subject you to spurious rules and regulations, ignore y

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

ur involuntary bodily functions, and physically abuse you, all with impunity, you just have to

.

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

say, flying sucks.

I have absolutely no sympathy when these companies hit the skids and fall

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

Companies that provide selfless information through particip

into bankruptcy.

They, and their workers, deserve to be mothballed, and the sooner the better

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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