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School Buses

When approaching a school bus: Slow down; If the amber lights are fla

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

shing, the bus is about to stop; If the red lights are flashing, the bus is stopped

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

Examples of combination products may in

In many states it is against the law to pass a school bus with flashing red lights

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

and/or an extended stop arm.

Do not upset school bus drivers. Many are not paid ve

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

y well and certainly don’t deserve the aggravation. There are many type of transport

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

Combination pro

tion companies and agencies which drive buses and all have slightly different policie

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, so expect just about anything, they are human and can make mistakes too. Here are

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

some of the School Bus Companies and Agencies out there:

Private schools; Public sch

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

ool districts; Ryder leasing; Russell bus lines; Durham Transportation; Laidlaw; Et

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

.

Make sure you maintain good public relations with these drivers. Also, realize th

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

t if you do something stupid near a school bus; it will be noticed by others. They w

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

Following aspects would a

ill think you are unsafe, which is a bad image. Don’t think for a second no one will

dd to the challenges in developing combination products:

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

notice. After all logo on your company vehicle sticks out. Save yourself a free tic

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

ket to traffic school and negative comments from teachers, bus drivers, parents and o

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

her motorists.

Proper etiquette when driving the company vehicles is important no ma

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

ter who is driving, you should make a point of discussing this with all your drivers.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Sometimes delivery drivers get in a bit of a hurry or anxious about completing all

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

he deliveries on time. Let them know that you do not want them to dilly dalley, but y

.

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

ou certainly expect them to courteous, safe and smart about the way they drive, child

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

Companies that provide selfless information through particip

en’s safety depends on it as well as the longevity of your business in that community

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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